1158 Pharmacovigilance Jobs - Page 4

Job Overview Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost effective manner. The individual will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary Of Responsibilities Assume accountability of quality of the deliverables and implementation of quality processes with minimal support from the Manager. Function as a Point of Contact for the delivery team for regulatory updates, quality concepts, applicable procedures, practices, and conventions on the assigned projects. Act as the process and quality expert for the Client. Work with other team members to analyze Quality findings and help develop action plans. Ownership of responding to and addressing periodic client quality reviews and other ad-hoc client quality findings. Perform ongoing review of a sample of various cases or safety reports for global regulatory submissions, labeling / regulatory documents for Fortrea clients e.g., Annual Reports (IND and other), PSURs, PADERs, Clinical Study Reports, Core Data Sheets, USPI, centralized SPC’s, Med Guides etc. Assist with the overall functional quality operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Provide adequate oversight to ongoing sample case reviews and perform reviews as required. Publish quality metrics based on this review and use it to ensure deliverables meet agreed quality targets. Identify, report quality trends to internal and external stakeholders, suggest corrective actions and monitor the execution and closure. Assume ownership of quality of reports and CAPAs as assigned. Ensure that CAPAs are implemented for the assigned project. Conduct process review in coordination with Project Manager and Quality Manager to identify process gaps and proactively coordinate with the delivery team to develop process standards and suggest process improvements. Measure and track audit readiness for assigned projects. Lead authoring, reviews, training and distribution of SOPs, project specific Work Instructions / convention documents etc. Work with individuals in identifying training needs based on quality review findings. Assist in designing sign-off criteria, development and tracking of training schedule and training material for new hires and existing team. Ensure that periodic feedback is provided to the team based on review findings. Initiate discussion forums on Quality errors within assigned project and identify process improvements, share best practices across projects. Communicate with internal Subject Matter experts to get clarification on case-processing queries and providing feedback to team. Responsible to coordinate and handle queries during the client or external audits of the assigned projects. Assume accountability of supporting the client during regulatory inspections and ensuring quality and timely completion of inspection requests. Responsible for developing Quality Management Plan and / or contributing to the Quality Agreement for assigned projects. Support Computer System Validation related activities as required. To respond/review to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc. Review recorded information that may be received over the telephone call, email, fax etc. Execute drug safety data management processes - a combination of call intake review, call dialogue documentation review and case follow-up. Guide safety associates in managing voice calls (as required). Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources. Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Manager. Perform Analysis of data and if required, suggest strategies for process improvement/excellence. Perform and Review of analysis of data performed and drive strategies for process improvement/excellence. All other duties as needed or assigned. Qualifications (Minimum Required) Bachelors/Masters/PhD degree in Medicine or Alternative medicine, Medical Science, Pharmaceutical science, Nursing, Life Sciences, or related area. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required) Five years of overall work experience in the pharmaceutical industry, biotechnology, or CRO industry primarily in Pharmacovigilance / Safety writing with at least Two years’ experience in Peer review/Quality review. Knowledge of regulatory requirements viz. GPV and applicable EU and FDA guidelines. In-depth understanding of case processing and assessment. Knowledge of Quality Assurance. Awareness of lean methodology concepts. Technical proficiency with Microsoft Office suite of applications. Preferred Qualifications Include Experience in generating quality metrics with trend analysis, authoring, and coordinating Corrective and Preventive Action Reports is preferred. Experience in assessing quality of a case/safety report from a medical, scientific and documentation perspective is preferred. Physical Demands/Work Environment Office Environment . Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location. Learn more about our EEO & Accommodations request here. Show more Show less

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice. Clinical Operations Manager POSITION PURPOSE The COM 2 is a regional role that provides expertise across all aspects of clinical site management and/ or study management for assigned Phase I – IV studies. The COM 2 operates in line with Good Clinical Practices (ICH-GCP), applicable regulatory and legal requirements and Bayer’s standard operating procedures. The COM 2 may be assigned work packages in areas of study start-up, site management and study management on a regional level. Either one or a combination of these work packages may be allocated to the position holder according to expertise, skill set and capacity requirements in a flexible way. The COM 2 must acquire knowledge and adequate training for work packages assigned and become proficient in independently executing assigned responsibilities. A work package is any combination of the individual responsibilities listed below. Work packages are not fixed, can be allocated per study, and distributed within the team. Allocation and distribution of responsibilities must adhere to Bayer’s standard operating procedures, including any requirements for independent review and oversight. ROLE AND RESPONSIBILITIES STUDY MANAGEMENT Lead and oversee all operational aspects of site management on a regional or study level from protocol feasibility to study archive. Serve as the representative for site management on the core study team. Contribute to the development of the protocol, study overview, monitoring strategy and Risk Based Quality Management with regards to monitoring and operational aspects. Responsible and accountable for developing the monitoring plan and the study-specific training plan. Key contributor in the development of recruitment and retention strategies and tools. Act as key study contact for assigned countries. Responsible for overall deliverables regarding timelines, budget, and quality in assigned countries. Ensure participating country commitment aligns with study commitments. Provide the information required to effectively monitor and manage study activities, ensuring all relevant IT systems are updated with precise and current data. Oversee monitoring activities and ensure sponsor oversight through monitoring report review and co-monitoring visits. SITE MANAGEMENT Act as primary contact for investigational sites. Verify site qualification, ensure the Investigator, and site staff meet all aspects of study delivery and commitments from site selection through close out. Train the Investigator and site staff on study protocol, relevant systems and operational aspects of study conduct. Monitor trial conduct in compliance with the study protocol, ICH-GCP and applicable regulatory requirements on time and quality. Ensure completeness of the Investigator Site File. Prepare and conduct onsite and/or remote monitoring activities according to monitoring plan, including complete reporting and follow up. CLINICAL CUSTOMER ENGAGEMENT Cultivate and sustain customer relations with clinical trial sites, ensure effective communication, drive fit for purpose processes and work towards enhancing overall site satisfaction and engagement. Establish and develop strong professional relationships with clinical investigators to expand/ maintain clinical research partnership opportunities. Cross functional collaboration to ensure alignment of priorities and deliver the portfolio. Influence and challenge internal and external factors to improve clinical research delivery. STUDY START-UP Lead study start-up activities in collaboration with local team. Provide input on site activation strategy. Collect and perform quality review of essential documents on country level such as IRB/IEC approvals, financial disclosure, CVs/medical licenses, etc. Compile and submit submission dossier (country dependent). Obtain any required approvals for relevant site documents (e.g., informed consent, financial disclosures). Prepare and distribute site start up documentation including Investigator Site File. Ensure timely filing of study documents at country and site level in Trial Master File (TMF). Ensure awareness of related local regulations and support maintenance of country intelligence. Provide study status monitoring and systems support (e.g. act as technical expert) Coordinate site and vendor payments. QUALITY Proactively identify and communicate issues, taking appropriate action to prevent the recurrence of identified deviations. Ensure timely and comprehensive resolution of issues that may affectcompliance or the quality of study related activities or data. Maintain corrective action and preventative action plans (CAPAs) at country level. Contribute to the preparation, conduct, and follow-up of Site Audits and Regulatory Inspections to ensure a successful outcome. Oversee completeness of country/site level eTMF and conduct QC for accuracy, completeness, and adherence to ICH/GCP and Bayer QSDs. OTHER Participate in expert working groups, project standard teams, and similar initatives. Contribute to global process improvement efforts. Share knowledge and experience with a coaching mindset Maintain therapeutic and technical expertise to enable discussions with investigators and site personnel. KEY WORKING RELATIONS: Internal: Locally and regionally with other COM 2s, medical affairs, pharmacovigilance, regulatory affairs, legal and other functions. Globally with study team members, QA & Inspection management. External: With site personnel, third party vendors, health authorities, IRB/EC, and inspectors, thought leaders including steering committee members, national leaders and/or other committees. WHO YOU ARE: Healthcare related Bachelor’s Degree or equivalent with minimum 4 years of monitoring and site management experience. Or have a combination of education and minimum 8 years of monitoring and site management experience. Other qualifications: Fundamental project management skills Awareness & understanding of cultural and regional differences Communication, oral presentation & interpersonal skills Decision making Issue resolution Planning and organization, time management, prioritization Thrives in ambiguous and collaborative environments and embraces change Effective written and verbal English communication skills Willingness to travel to sites, study meetings, local and international level Ever feel burnt out by bureaucracy? Us too. That’s why we’re changing the way we work— for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here https://www.bayer.com/en/strategy/strategy Bayer does not charge any fees whatsoever for recruitment process. Please do not entertain such demand for payment by any individuals / entities in connection with recruitment with any Bayer Group entity(ies) worldwide under any pretext. Please don’t rely upon any unsolicited email from email addresses not ending with domain name “bayer.com” or job advertisements referring you to an email address that does not end with “bayer.com”. YOUR APPLICATION Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation etc. We are committed to treating all applicants fairly and avoiding discrimination. Location: India : Karnataka : Bangalore || India : Maharashtra : Thane Division: Pharmaceuticals Reference Code: 848115 Contact Us + 022-25311234

Job Overview It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. The individual will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary Of Responsibilities Perform Quality review of assigned cases. Assist in compiling quality metrics based on this review and identifying quality trends. Assist in addressing periodic client quality reviews. Assist in preparation of Corrective and preventive actions as requested. Assist in ensuring that CAPA results are implemented and produce documentary evidence to that effect in coordination with the project managers. Perform ongoing review of a sample of various cases or safety reports for global regulatory submissions, labeling / regulatory documents for Fortrea clients e.g., Annual Reports (IND and other), PSURs, PADERs, Clinical Study Reports, Core Data Sheets, USPI, centralized SPC’s, Med Guides etc. Assist with the overall functional quality operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Assist in the conduct of process review for assigned process and measure and monitor audit readiness. Assist in designing and tracking training schedule and training material for new hires and existing team. Contribute to discussion forums on Quality errors within assigned project and help identify process improvements. Assist in coordinating respective client or external audits of the assigned projects as requested. Assist in development of Quality Management Plan for assigned project. Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Lead / Quality Manager. Perform Analysis of data and if required, suggest strategies for process improvement/excellence. Perform and Review of analysis of data performed and drive strategies for process improvement/excellence. To respond/review to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc. Review recorded information that may be received over the telephone call, email, fax etc. Execute drug safety data management processes – a combination of call intake review, call dialogue documentation review and case follow-up. Guide safety associates in managing voice calls (as required). Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources. Contribute to process review and use results to identify the process improvement initiatives. Coordinate with the project team to support sponsor during the regulatory inspections or audits as applicable. Review of product quality complaints, medical/general information queries and respond back to reporter/consumer as per agreed procedures and captures this information in required formats agreed with Sponsor. Review of a sample of various safety reports for global regulatory submissions for Fortrea clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports, Investigator brochures and sections of protocols, Clinical Study Reports etc. All other duties as needed or assigned. Qualifications (Minimum Required) Bachelors/Masters/PhD degree in Medicine or Alternative medicine, Medical Science, Pharmaceutical science, Nursing, Life Sciences, Biological Sciences, or related area. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required) Two plus years of overall work experience in the pharmaceutical industry, biotechnology, or CRO industry primarily in Pharmacovigilance / Safety writing with some experience in Peer review/Quality review. Ability to present and share useful business information across departments and functions. Ability to anticipate and identify problems and take appropriate action to correct. Knowledge of medical and drug terminology. Knowledge of Good Clinical Practice (GCP) and GVP requirements related to clinical safety and post marketing documentation. Knowledge of ICH Guidelines. Knowledge of worldwide regulatory requirements and reporting of adverse events for both marketed and investigational products. Knowledge of regulatory requirements viz. GPV and applicable EU and FDA guidelines. In-depth understanding of case processing and assessment. Technical proficiency with Microsoft Office suite of applications. Preferred Qualifications Include Experience in generating quality metrics with trend analysis, authoring, and coordinating Corrective and Preventive Action Reports is preferred. Knowledge of Medical Device reporting desirable. Physical Demands/Work Environment Office Environment Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location. Learn more about our EEO & Accommodations request here. Show more Show less

Job Overview It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. The individual will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary Of Responsibilities Perform Quality review of assigned cases. Assist in compiling quality metrics based on this review and identifying quality trends. Assist in addressing periodic client quality reviews. Assist in preparation of Corrective and preventive actions as requested. Assist in ensuring that CAPA results are implemented and produce documentary evidence to that effect in coordination with the project managers. Perform ongoing review of a sample of various cases or safety reports for global regulatory submissions, labeling / regulatory documents for Fortrea clients e.g., Annual Reports (IND and other), PSURs, PADERs, Clinical Study Reports, Core Data Sheets, USPI, centralized SPC’s, Med Guides etc. Assist with the overall functional quality operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Assist in the conduct of process review for assigned process and measure and monitor audit readiness. Assist in designing and tracking training schedule and training material for new hires and existing team. Contribute to discussion forums on Quality errors within assigned project and help identify process improvements. Assist in coordinating respective client or external audits of the assigned projects as requested. Assist in development of Quality Management Plan for assigned project. Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Lead / Quality Manager. Perform Analysis of data and if required, suggest strategies for process improvement/excellence. Perform and Review of analysis of data performed and drive strategies for process improvement/excellence. To respond/review to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc. Review recorded information that may be received over the telephone call, email, fax etc. Execute drug safety data management processes – a combination of call intake review, call dialogue documentation review and case follow-up. Guide safety associates in managing voice calls (as required). Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources. Contribute to process review and use results to identify the process improvement initiatives. Coordinate with the project team to support sponsor during the regulatory inspections or audits as applicable. Review of product quality complaints, medical/general information queries and respond back to reporter/consumer as per agreed procedures and captures this information in required formats agreed with Sponsor. Review of a sample of various safety reports for global regulatory submissions for Fortrea clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports, Investigator brochures and sections of protocols, Clinical Study Reports etc. All other duties as needed or assigned. Qualifications (Minimum Required) Bachelors/Masters/PhD degree in Medicine or Alternative medicine, Medical Science, Pharmaceutical science, Nursing, Life Sciences, Biological Sciences, or related area. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required) Two plus years of overall work experience in the pharmaceutical industry, biotechnology, or CRO industry primarily in Pharmacovigilance / Safety writing with some experience in Peer review/Quality review. Ability to present and share useful business information across departments and functions. Ability to anticipate and identify problems and take appropriate action to correct. Knowledge of medical and drug terminology. Knowledge of Good Clinical Practice (GCP) and GVP requirements related to clinical safety and post marketing documentation. Knowledge of ICH Guidelines. Knowledge of worldwide regulatory requirements and reporting of adverse events for both marketed and investigational products. Knowledge of regulatory requirements viz. GPV and applicable EU and FDA guidelines. In-depth understanding of case processing and assessment. Technical proficiency with Microsoft Office suite of applications. Preferred Qualifications Include Experience in generating quality metrics with trend analysis, authoring, and coordinating Corrective and Preventive Action Reports is preferred. Knowledge of Medical Device reporting desirable. Physical Demands/Work Environment Office Environment Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location. Learn more about our EEO & Accommodations request here. Show more Show less

Req # JR - 174630 Location Gurgaon, Haryana, India Job Category Patient Safety Date posted 06/12/2025 Apply Now This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission. Job Title - Medical Reviewer Location: Gurgaon Summary The Medical Reviewer (MR) is responsible for: Provide medical review for individual case safety reports, including: coding, seriousness, expectedness, Baxter causality assessment. Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment. Potential review of periodic documents, and product labels. Essential Duties And Responsibilities Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment. Provide medical and scientific expertise on pharmacovigilance matters affecting the preparation and submission of timely and accurate information to the regulatory authorities. Support the Safety Operations team, providing expertise for the case processing team for medical questions e.g., coding of events, understanding coding conventions, splitting of cases etc. Maintain knowledge of global regulatory authority regulations (especially FDA and EMA). Contribute to the training, leadership and continuing education for all departmental staff. May perform benefit-risk safety analysis, including: safety surveillance activities for potential safety signals, aggregate safety data review, risk management plans and REMS, Regulatory Authority assessment reports and queries, and periodic documents, such as PSURs, PBRERs, and PADERs. Qualifications Knowledge of industry regulations and drug safety practices globally. Knowledge of adverse event case report triage processing. Experience with commercial databases and safety coding dictionaries (MedDRA, WHOART, COSTART, etc.). Excellent oral and written communication skills. Excellent teamwork and interpersonal skills are required. Strong skills in presenting drug safety topics for regulatory authorities or at conventions, meetings, etc. Education And/or Experience A medical degree (or equivalent) and board certification/eligibility are required. Two years of experience post-residency, with at least one year of experience in pharmaceutical/biotechnology company. Exposure to working relationship with FDA, EMA, or other regulatory authorities is preferred. Knowledge and understanding of national and international regulatory guidelines are a plus. Knowledge of medical aspects of drug safety in pre- and post-marketing safety practice. At Baxter, we offer a dynamic and future focused work environment offering workplace flexibility, additional annual leave and a strong value driven culture. Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. EEO (Equal Employment Opportunity) Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice. Apply Now Show more Show less

Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Associate Qualifications: Master’s in actuarial science Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements. Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for? Candidates who have completed Master s or Post graduate degree in Life Science domain (Biology, Genetics, Microbiology, Biochemistry, Biotechnology, and Ecology) in 2024 & 2025 (if all semester s results are available). Adaptable and flexible. Ability to perform under pressure. Problem-solving skills. Ability to establish strong client relationship. Agility for quick learning. Experience with Clinical testing, Understanding of clinical Trials, Phases and clinical domain. Familiarity with clinical data management concepts and terminologies, Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. Experience in test script development and strong documentation skills for test cases, validation reports and audit trials. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Show more Show less

Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Associate Qualifications: Master’s in actuarial science Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements. Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for? Candidates who have completed Master s or Post graduate degree in Life Science domain (Biology, Genetics, Microbiology, Biochemistry, Biotechnology, and Ecology) in 2024 & 2025 (if all semester s results are available). Adaptable and flexible. Ability to perform under pressure. Problem-solving skills. Ability to establish strong client relationship. Agility for quick learning. Experience with Clinical testing, Understanding of clinical Trials, Phases and clinical domain. Familiarity with clinical data management concepts and terminologies, Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. Experience in test script development and strong documentation skills for test cases, validation reports and audit trials. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Show more Show less

Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Associate Qualifications: Master’s in actuarial science Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements. Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Ability to establish strong client relationship Agility for quick learning Candidates who have completed Master s or Post graduate degree in Life Science domain (Biology, Genetics, Microbiology, Biochemistry, Biotechnology, and Ecology) in 2024 & 2025 (if all semester s results are available). Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Show more Show less

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Physiotheraphy Years of Experience: 0 to 1 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Junior Drug Safety Associate Junior Drug Safety Associate Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Show more Show less

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us Your Role Generate or convert doctors for our product portfolio. Secondary sales – Ensuring to achieve secondary sales targets through prescription generation by each of his BE. Good at relationship with KOLs (Top Physicians, Endocrinologists & Cardiologists) Day to day sales reporting Effective query handling and customer queries. Ensuring 100% Implementation of Company’s strategies Pharmacovigilance (Adverse Event Reporting) – To collect adverse drugs reaction (ADR) incidences including lack of efficacy related to medicinal products up to the maximum possible level of completeness and forward to local Patient Safety team immediately within 24 hours of ADR awareness. The additional information can be submitted as soon as possible Who You Are Any graduate Freshers or minimum of 1-2 years of experience in any pharma company Should have strong product knowledge & communication skills What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team! Show more Show less

SUMMARY SAR & SAR-like Patient Safety Physician Job Description Responsible for compiling PBRERs with a focus on medical aspects and safety sections of products, and analyzing safety trends, including source data analysis based on queries Assisting in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborating with Therapeutic Head to identify signals and address product safety concerns Engaging with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensuring 100% compliance with timely completion of all client and Cognizant required trainings Achieving 100% compliance with work allocation plan, including case closure based on agreed timelines and quality benchmarks Non - Measurable Attributes Self - motivated Goal-oriented Interdepartmental collaboration Personal grooming and etiquette Punctuality Team player and process-oriented Competencies Proficient in delivering presentations Effective at collaborating across different cultures Strong preference for structured and process-driven tasks Committed to completing training and documentation on time Experience Relevant educational background and experience in patient safety or related field Required Skills Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities Requirements Requirements: Relevant educational background and experience in patient safety or related field Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities

Primary Responsibilities: To be an effective participant in Class room training and clear the training assessments with 85% quality Consistently meet the targets set for MOCK charts Eligible employee will get confirmed as Junior Coder within a max of 6 months from the Joining Punctuality, Attendance and General Adherence to company policies, procedures and practices Strives to provide ideas to constantly improve the process Ensure adherence to external and internal quality and security standards (HIPPA/ISO/ISMS) Be an effective team player Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do so #NTRQ Eligibility To apply to an internal job, employees must meet the following criteria SG 22 can apply will move laterally Performance rating in the last common review cycle of "Meets Expectations" or higher Not be on any active CAP (Corrective Action Plan) or active disciplinary action Time in Role Guidelines Should have been in your current position for a minimum of 12 months, if you have not met the recommended minimum time in role, discuss your career interest with your manager and gain alignment prior to applying. And share the alignment email with respective recruiter while applying Required Qualifications: Any degree in Life Science or Bio-Science Any degree in Pharmacy or Pharmaceutical Sciences Any degree in Nursing or Allied Health Any degree in Medicine

Position Summary This role will be responsible for in-patient journey analysis and working with patient-level data to develop a robust solution for the client's teams. An expert in Patient Analytics who can guide and lead the team supporting pharma clients Job Responsibilities Effectively manage the client/ onshore stakeholders, as per the business needs, to ensure successful business delivery. Work closely with the project manager to define the algorithm, break down the problem into execution steps, and run the analysis Ensure high-quality analytics solutions/reports to the client Delivery role will include project scoping, solution design, execution, and communication of the analysis in the client-ready formats Contribute towards Axtria tools and capabilities as per the business requirements. Build organization capabilities by participating in Hackathon, solution design, and process automation Effectively communicate with onshore/ client (as per business needs) Education Bachelor of Engineering in Statistics Work Experience Behavioural Competencies Teamwork & Leadership Motivation to Learn and Grow Ownership Cultural Fit Project Management Communication Technical Competencies Python R SQL EXCEL MMx Forecasting Machine Learning Pharma Commercial Know How HEOR EPI and Economic Analysis HEOR Simulation Analysis Patient Data Analytics Know How Dataiku KNIME Others

This job is with ICON plc, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Senior Auditor, Quality Assurance- Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Auditor Quality Assurance to join our diverse and dynamic team. As a Senior Auditor Quality Assurance at ICON, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of in Native treatments and therapies. Job Location: Bangalore (Remote Based) Responsibilities And Qualifications Manage complex Quality Issues to include supporting Root Cause Analysis, Impact Assessment and appropriate Corrective Action and Preventive Action (CAPA) Plans. Respond to audit findings and support audit responses to assess compliance with corporate policies, industry standards, and applicable regulations. Lead/Support regulatory Inspection hosting Lead/Support Sponsor Audit Hosting Independently conducts the following activities as assigned by Quality & Compliance (Q&C) management Manage Quality Issues Lead Quality Issue Investigations Supports Operations in Root Cause Analysis and CAPA Plan preparation. Support Effectiveness Check development and outcomes. Assist with the implementation and maintenance of an effective Quality Management System/ Quality Assurance program within the relevant Quality & Compliance (Q&C) team. Perform departmental and ICON staff training regarding ICON’s quality system, Q&C tasks and processes, applicable standards, and regulations. Mentor new or developing Q&C staff as assigned. Support business development activities and Q&C initiatives as needed. Host regulatory inspections of the site/ICON/Sponsor as Lead Host or Co-host Host Sponsor audit ICON as Lead Host or Co-host What You Will Have 5 years’ experience working in a clinical, regulatory, pharmacovigilance, or quality environment within CRO/ pharmaceutical / healthcare industry. Advanced knowledge of GCP (Good Clinical Practice) Excellent organizational skills. Must possess a technical knowledge that is applicable to clinical drug development. An undergraduate degree, its international equivalent in the sciences, technology, auditing, etc. from an accredited institution or sufficient previous experience in auditing is required Excellent knowledge of MS Office (including Microsoft Word, PowerPoint and Excel). Critical thinker that sees the "big picture" (e.g. overall themes, trends, goals), generates innovative ideas and solutions to problems and makes recommendations in the face of complexity, conflicting pressures and ambiguous circumstances. Professional communicator, able to gain and maintain a trusted relationship while delivering difficult messages Team worker, able to listen to others but also influence in order to see the wider picture and achieve a vision Read, write and speak fluent English. What ICON Can Offer You Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply Show more Show less

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait . We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries. For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets). ‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization. Job Description Job Summary We are seeking a dynamic independent and experienced Research Associate in Clinical Management for processing, reviewing and receiving clinical data and records and from therapeutic groups as well as internal and outside investigators. Ensuring accurate, timely, and consistent data reaches the clinical teams and other groups. Roles & Responsibilities Responsibilities Facilitate Study Start up activities at Clinical Investigational Site Conduct Feasibility & assess the data Conduct site qualification visits to assess suitability of sites for study conduct including review of Investigator qualifications, site staff adequacy, site facilities, patient pool & share feedback to project team Collection of essential documents including validation records for site equipment from selected sites for regulatory and EC submissions Identify the training needs for the site to perform adequate conduct of trial Ensure supply of clinical trial material to sites before study initiation End to End clinical investigational site management: Initiate the study at clinical investigational sites Provide study protocol and related trainings Perform review of Informed Consent forms and narrative Perform review of source records, perform SDV Review of CRF data entry, data queries and coordinate with sites to resolve Ensure timely completion and review of site visit reports and addressing action items via follow up letters, tracking of action items till closure IP accountability and reconciliation Ensure adequate initial supply & re-supply of IP per study plan to clinical trial sites Provide adequate oversight to IP collection, storage, temperature monitoring including review of log, administration to study subjects Identification of any temperature excursions and suitability of IP for subject administration Ensure destruction of expired / used IP on site or return of such IP back to local depot, per study requirement & adequate documentation for same. Review of completion of logs, filing of relevant shipment etc. documentation in site / pharmacy file. Site Contracts and Site Payment Coordination Coordinate for CDA, Clinical trial agreements review and finalization and amendments, as applicable Ensure that site invoices are being generated as per clinical trial agreement Review and approval of site invoices and submission to payment processing team Coordinate for the payment release & confirm for site acknowledgements Perform ongoing reconciliation of payments against site activities including subject visits conduct etc. Liaising with safety lab for timely samples receipt, processing and release of reports & identify, resolve any issues / risks around same. Ensure that the Bio-analytical samples are stored as per storage conditions mentioned in the lab manual including reconciliation and query resolution Liaising with other vendors and help sites in any query resolutions for vendor related activities Liaising with internal project teams including but limited to Data Management for EDC issues, data queries and reconciliations, Safety team for SAE related issues, Medical team for any protocol / eligibility related queries etc. Liaising with Internal & External Stakeholders Ensuring Compliance to Protocol & Applicable study plans, SOPs, GCP and regulatory requirements Ensure compliance to Protocol Ensure compliance to study plans, applicable SOPs and related regulatory requirements Ensure compliance to ICH GCP Ensure compliance to good documentation practices including ALCOA-C Identification of significant deviations to protocol / plans / procedures, escalation to project lead / clinical ops lead and propose adequate mitigation plans / CAPA, Review of implementation of CAPA / mitigation plans, identify need for training and provide training / re-training in case of any changes Support audits, inspections / QC visits, as required per study plans Trial Master File Review and Maintenance for Inspection Readiness Ensure that sites are timely updating the documents in Investigator site file Retrieval of essential documents from sites for In house filing / Central files Review of onsite and in house files at defined frequency per monitoring / TMF plan for study Ensure adequacy of TMF for all time inspection readiness Qualifications Educational qualification: Master degree in pharmacy/ life science/Biology/Biotechnology/ Biochemistry/Diploma in Clinical Research Minimum work experience: 3 - 6 years of research experience Skills & attributes: Technical Skills Experience in Clinical Trial operations. Proficiency in conducting Market research and analysis. Knowledge of regulatory requirements and guidelines such as Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines. Ability to evaluate medical research data and proficient knowledge of medical terminology Proficiency in using EDC systems for data collection and management in clinical trials. Understanding of pharmacovigilance processes. Strong MS office Skills. Behavioral Skills Excellent communication, negotiation, and interpersonal skills. Excellent project management skills. Strong analytical and problem-solving abilities with a keen eye for detail. Result oriented and passionate about delivering value. Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/ Show more Show less

Key Accountabilities : Technology Support Under supervision, conduct set-up and support activities associated with the Parexel safety database (and associated systems) including but not limited to new study set-up - Periodic report configuration and generation with oracle Analytics. Ad-hoc report configuration and generation with oracle Analytics. Expedited report rule configuration with oracle Analytics. End-user support. Provide support in the planning and delivery of the handover of the safety database from client to Parexel were contracted to take over the pharmacovigilance tasks for client projects. Provide support in the planning and delivery of the handover of safety data from Parexel to client at the end of study/project as contracted. Adhere to standard operating procedures and controlled documents that pertain to safety technology. Organizational Representation Interface with other Parexel groups (such as TQM, QA, IT) to ensure that database, hardware, network, security, quality, integration, support and project services associated with maintained systems are adequate and sufficiently managed. Support colleagues when working with external auditors and inspectors during the examination of safety technology. Issue Management Under supervision, collaborate with Parexel IT, vendor, Parexel Safety Services staff, and clients for the proper analysis, resolution, and closure of issues for supported systems. Team Support Provide support to new staff in the systems and activities necessary for the fulfillment of their job responsibilities. Change Management Under supervision, support change management in accordance with the Software Development Life Cycle. Under supervision, support execution of tasks for software updates, change requests and application support for the supported applications. Under supervision, support the implementation of technology solutions for Safety Services for the purposes of business process optimization and improvement. Ensure adherence to regulations concerning computer system validation, 21 CFR Part 11 compliance, procedures, and quality standards. Skills: Good interpersonal, verbal, and written communication skills. Client focused approach to work. Good analytical and problem-solving skills. Good organizational and customer service skills. Willingness to work in a matrix environment and to value the importance of teamwork. Provide support to a team working through problem management. Under supervision, take ownership of core tasks related to the support and maintenance of safety technologies. Basic System Administration and application support skills within pharmacovigilance. safety technology, including at least one of: safety databases, gateway / E2B, report development, signal detection. Basic skills in using standard scripting languages e.g., SQL. Knowledge of industry standard Service Desk Tools. Basic technical writing capability. Knowledge of standard SDLC processes including change management. Knowledge of Agile methodology. A flexible attitude with respect to work assignments and new learning. Under supervision, complete multiple and varied tasks with enthusiasm and prioritize workload. Knowledge of system validation and change management. Basic knowledge of computer system regulations and guidance in the pharmaceutical industry including: 21 CFR Part 11, EMA Annex 11, GAMP. Basic knowledge of Pharmacovigilance roles, standards and practices. Basic knowledge of GVP and GCP. Education: Bachelor’s degree in engineering/computer science, master's or equivalent preferred.

JOB DESCRIPTION As a Therapy Business Manager you will be responsible for developing and implementing all sales strategies in the assigned market. Further you will drive primary and secondary sales, ensure brand presence in the assigned market and manage the distributor network to achieve desired sales/business objectives. Roles and Responsibilities in detail Business generation & development: Achieve monthly, quarterly, half yearly and yearly sales target by promoting company’s product ethically to customers as per the business plan Having science-based discussion with doctors and chemists for promotion of product in clinic and at chemist place Organizing Camps (CME) as per the division strategy and customer needs To plan and conduct merchandising and sampling activity as per Division strategy. Facilitate the process of successful new product / products launch in the territory by undertaking correct identification and targeting customers for the new product, meet them at pre-determined intervals, effective in clinic / trade promotion and share feedback with the company Execute the customer management plan to ensure that all the customers are covered as per the plan and meet minimum KPIs as follows: a. 100% coverage of Doctors. b. Customer Call average as per the customer management plan of the division / therapy. c. Market intelligence collection, retailer level inventory management calls as per the product profile and marketing strategy of the therapy / division. Prescription audit for Abbott brands and other competitors’ brands To create and update customer list having specified number of doctors / chemist (Trade) as per the therapy / product requirement and maintain the same in physical / electronic format. Identifying potential town and appointing distributor and customers (trade) in line with business philosophy Brand Management: Ensuring the visibility of Abbott brands on retailers’ outlet as a part of brand promotion strategy To carry out activities across trade and clinics for brand visibility To plan and attend Retail meets, Market Blitz etc. for sales growth Generate POBs for Abbott brands as per the business plan Recommend appointment of a party as a distributor after evaluating its commercial standing, credit worthiness and personal assets. Ensure that stock and sales statements have been sent by the distributors on due dates Ensure that the claims of the distributors are settled by company within specified time limits You are manager of the company in your territory and will be authorized to build company’s reputation in your territory. You will be responsible for practicing and leading other junior team members of the company by setting personal example of excellence in: 1. Lead and execute strict adherence to Abbott Code of Business conduct 2. Set examples on implementation of the code of business conduct, FCPA , Pharmacovigilance to ensure compliance 3. Conformation to all financial and administration systems, compliance to statutory and regulatory norms of the company and laws of the land 4. Demonstrate and promote professional behavior in line with Abbott Values of Pioneering, Achieving, Caring and Enduring 5. Ensure high level of customer service and manage any difficult customer situations. 6. Ensure compliance with internal and external guidelines and ensure minimal comments in audits and other inspections 7. Ensure transactions and orders are processed with a high level of accuracy and commitment in order to satisfy customer needs 8. Manage attrition of customer and resource bases 9. Division and business strategy will be shared with you on time to time base which you will have to execute to the fullest 10. To attend and participate in Strategy meetings, briefing sessions, doctors meets, workshops, training programmes and any other programmes undertaken by the company to equip you or activities for performance of your job or promote the sales of product of the company or to improve company image. 11. Ensure adherence to EHS policies, procedures, rules and regulations. Attend all required EHS trainings as applicable. Wear safety gears (e.g. Helmet) while riding on two-wheeler. Report any EHS incidents and/or near misses (unsafe acts and conditions) promptly to supervision. Forward any opportunities to improve the EHS program to supervision. Authorized Signatory

Job Overview Location - Kolkata only Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members. Essential Functions To Prioritize and complete the assigned trainings on time Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information determining initial/update status of incoming events database entry coding AE and Products, writing narratives, Literature related activities. Assuming other workflow responsibilities for the assigned project as directed by Operations team member or Manager. Ensure to meet the expected productivity and quality standards Ability to identify quality problems, if any, and bring them to the attention of a senior team member/ mentor. Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes. 100% compliance towards all people practices and processes Perform other duties as assigned Qualifications High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences An Individual with a minimum of a Bachelor’s Degree in scientific or healthcare discipline or allied life sciences graduation. Good knowledge of medical terminology. Strong verbal/written communication skills. Ability to work as a Team Player, contribute and work towards achieving Team goals. Good working knowledge of Microsoft Office and web-based applications. Self-motivated and flexible. Attention to detail and accuracy. Ability to follow instructions/guidelines, utilize initiative and work independently. Ability to manage competing priorities and deadlines. Willingness and aptitude to learn new skills across Safety service lines. Strong time management skills. Ensure quality of deliverables according to the agreed terms. Demonstration of IQVIA core values while doing daily tasks - Extensive use of keyboard requiring repetitive motion of fingers. Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Regular sitting for extended periods of time. May require occasional travel. Flexibility to operate in shifts. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

Job Overview Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business. Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. He/she will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary Of Responsibilities Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to: Data entry of safety data onto adverse event database(s) and tracking systems. Review of adverse events for completeness, accuracy and appropriateness for expedited reporting. Write patient narratives and code adverse events accurately using MedDRA. Determine listedness against appropriate label (for Marketed products, if applicable). Identifies clinically significant information missing from the reports and ensures its collection and follow-up. Ensure all cases that require expediting reporting to worldwide Regulatory Agencies and other required parties are processed swiftly and appropriately within required timelines. Reporting of endpoints to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required, within study specified timelines. Submission of expedited Serious Adverse Event (SAE) reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required and as agreed with client during study set-up, within study specified timelines. Perform Database reconciliation with Data Management team or sponsor/client as needed. Perform processing and/or review and submission of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs), including but not limited to: Maintenance of adverse event tracking systems. Set-up and maintenance of project files and central files for documentation. Assist with the reporting of ESRs and PSRs to clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel, as required, within study specified timelines. Maintain a strong understanding of Fortrea’s safety database conventions or client specific database conventions, as appropriate. Perform quality review or peer review of processed reports and support the Line Management with trends and actions needed. Begin participating in signal detection and trend and pattern recognition activities, as appropriate. Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) like Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs) etc. Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided. Support/train/mentor less experienced safety staff in all aspects of case-handling, adverse event reporting. Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance. Assist with review and update of Safety Management Plans (SMPs), Reconciliation Plans, and other safety- specific plans ensuring optimal efficiency. Participate in Fortrea project team and client meetings, as appropriate. Prepare and support coordination of safety study files for archiving at completion of projects. Contribute to root cause analysis, including the CAPA plan development and implementation. Support Audits and/or inspections preparation. Assist in review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients, if applicable and coordination of end point committees. All other duties as needed or assigned. Qualifications (Minimum Required) Non-degree + 2 years of Safety experience * or 4-5 years of relevant experience** Associate degree + 2 years of Safety experience * or 3-4 years of relevant experience** BS/BA + 1-2 years of Safety experience * or 2-3 years of relevant experience** MS/MA + 1-2 years of Safety experience * or 2 years of relevant experience** PharmD + 1-2 years of Safety experience * or 2 years of relevant experience** For PharmD, a one-year residency of fellowship can be considered as relevant experience. Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area. * Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions. ** Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required) High degree of accuracy with attention to detail. Functions as a team player. Good Communication and presentation skills. Good written and verbal communication skills. Knowledge of medical and drug terminology desirable. Familiarity of Good Clinical Practice (GCP) related to clinical safety documentation. Familiarity with ICH Guidelines. Familiarity of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products. Ability to work independently with minimal supervision. Good keyboard skills, preferably with knowledge of MS office and Windows. * Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions. ** Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance. Physical Demands/Work Environment Office Environment. Available for travel 5% of the time including overnight stays as necessary consistent with project needs and office location. Learn more about our EEO & Accommodations request here. Show more Show less

Summary In line with overall product strategy, the Medical Advisor is responsible for supporting the design, implementation and execution of Medical Affairs plans for assigned Therapy Area, providing scientific information, helping design & organise clinical studies, building educational dialogue with KOLs and regulatory stakeholders About The Role Key Responsibilities Support country medical affairs strategy in line with the global strategy, country insights and market conditions, and implementation of Medical Affairs activities within the designated therapy area(s). Coordinate scientific meeting, symposia, congresses, Continuous Medical Education (CME) and other medical / scientific exchange and engagement activities which could bring value to the therapy area; develop engagement plan(s) for country customer-facing activities and events, and ensure timely execution of the activities in an efficient and compliant way. Ensure enquiries are responded to in a quality, timely manner, and in accordance with applicable standards; establish response documents for frequently asked questions. Provide medical/scientific input into the development and execution of clinical trial or clinical research related activities, including initiation and oversight of clinical studies / clinical research within the therapeutic area. Support country strategy for Non Interventional Studies/Investigator Initiated Trial activities. Coordinate review and approval of medical materials and locally developed promotional materials; ensure medical materials provided from global or region for partner engagement and events are tailored to local needs, and reviewed/approved per local/P3 guidelines. Ensure medical insights are provided to cross-functional groups, including, but not restricted to: Pharmacovigilance, Regulatory Affairs, Market Access, QA, Commercial and Brand team and others. Responsible for risk identification and assessment, mitigation planning as well as implementation and monitoring of appropriate internal controls within the area of responsibilities Essential Requirements MBBS; MD Mandatory with min 1+ year industry experience Operations Management and Execution Project Management Collaborating across boundaries Clinical Trial Design, Data & Reporting Medical Science and Disease Area Knowledge Medical Education and Scientific Engagement Non-Interventional Studies (NIS) / Epidemiology Studies Medical Governance and Medical Safety Desirable Requirements: Cardiovascular Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Commitment To Diversity And Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device. We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. Come and join us in this exciting journey to make a positive impact in patient’s lives. Job Description If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trial, to large, generic post-marketing teams. We are always looking for proactive, capable and motivated individuals who aim to surpass any target set in front of them. The PV Officer should be a Life science / bio medical background graduate or have other healthcare related degree qualification (chemistry, biology, biotechnology, veterinary science etc.) and have demonstrated experience in case processing. The PV Officer will be working as part of a project team, performing, and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance. PV Officers are expected to reach and maintain a high level of performance within 3 months of being assigned to an ICSR team, following onboarding completion. Responsibilities Include Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines. As a key member there is an expectation to effectively cover all steps of a workflow cycle, except Medical Review. Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations) Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.) Mentoring and training of new and more junior employees within the department, including procedure optimization and development Qualifications Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing Demonstrated case processing experience ARGUS experience preferred Time and issue management, delegation, organization and multitasking skills with good attention to detail Strong interpersonal and communication skills Advanced English skills, both verbal and written, at least C1 Additional Information Why PrimeVigilance? We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. We Offer Training and career development opportunities internally Strong emphasis on personal and professional growth Friendly, supportive working environment Opportunity to work with colleagues based all over the world, with English as the company language Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join! Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships We look forward to welcoming your application. Show more Show less

Job title : Scientific Sales Executive Location: Delhi Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally . Our mission is to bring health in people’s hands by making self-care as simple as it should be . For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands , our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets , we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. PURPOSE OF THE ROLE To achieve the area sales objectives and stretch beyond targets by increasing prescription from identified doctors through effective implementation of marketing activities. To support in organizing patient acquisition and retention programs Internal CSM, RBM, Supply Chain Manager, Product Manager, Assistant Manager – HR (Sales),Zonal OPTIMA coordinator, Zonal Finance, Regional Training Manager External Distributors, Doctors, Chemists, Pharmacovigilance, Sales Director MANAGEMENT / LEADERSHIP RESPONSIBILITY Organization To align with and participate actively in organization led initiatives periodically To understand and comply with the organization Code of Ethics Scope of Role (Team, Geographical, Material) Role based at the respective region assigned KEY RESULT AREAS Work Area Descriptors Performance Indicators People Capability Development - Attend all local and regional meetings and training programs and acquire and apply knowledge as disseminated through such programs. New Hire Induction - Impart field induction training to new joiners monitor progress and give feedback to superiors. Make product presentation and assist area manager in PCM’s whenever required. Assist CSM in collection and summarizing of SLP sales leadership in plan formats. Attendance and participation at local/regional meeting Attendance and participation in training programs/seminar Financial Sales Target Achievement - Achieve monthly, quarterly and annual sales targets as assigned by CSM/RBM Inventory Management - Forwarding of breakage & expiry of products within limits of authority. Customer Acquisition Budget Management - Decide and effectively utilize financial investment for doctors within the ethical guidelines of the group. Target achieved % Growth Process Efficient Day Planning - Plan day’s work with clear objectives for each call, perform pre and post call analysis and visits chemists for feedback. Market Intelligence - Keep track of movement of company products vis-à-vis competitor’s products and give regular feedback to superiors. Assist the CSM to identify appropriate target doctors. Report adverse events to Pharmacovigilance. Effective utilization of SFE tools OPTIMA and SLP guidelines for process excellence. Product Availability - Make the products available, follow-up and coordinate with the chemists and C&F to ensure adequate inventories of company’s products. Call average Frequency of coverage i.e. A & B Accuracy and timeliness of Data entered in OPTIMA Market & competitors feedback to superiors Adverse event reporting Customer Brand Building - Organize specific group events of doctors – organize logistics e.g. venue, date, & time, materials, etc. and co-ordinate with executive/product manager in compliance with the ethical framework of the company. Participate in the patient acquisition and retention campaigns, where applicable. Give post program feedback; follow up with participating doctors to increase demand. Inventory level recording Quality, timeliness and effectiveness of events organized % growth in patient acquisition and retention Feedback from retailers, distributors Role – Holder Entry Requirements Minimum Educational Qualification Any Graduate, preferably B.Sc or B.Pharma Relevant Work Experience Minimum Years Of Experience 2+ years of relevant experience Preferred Industry Experience Pharmaceuticals, Consumer Health Care Functional Knowledge Required Product Knowledge Knowledge of pharma industry Basic Financial Management Knowledge Skills Required Excellent oral and verbal communication skills Basic use of MS Office Business Acumen and entrepreneurial traits Influencing and negotiation skills Desired Competencies Act for Change Think strategically Strive for Results Lead Teams Commit to Customers Make Decisions Cooperate Transversally Develop People CAREER DEVELOPMENT OPPORTUNITIES The career path for the role can be vertically towards the Channel Sales Manager role Why us? At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day. We Are Challengers. We Are Dedicated To Making Self-care As Simple As It Should Be. That Starts With Our Culture. We Are Challengers By Nature, And This Is How We Do Things All In Together: We keep each other honest and have each other's backs. Courageous: We break boundaries and take thoughtful risks with creativity. Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity. Radically Simple: We strive to make things simple for us and simple for consumers, as it should be. Join us on our mission. Health. In your hands. www.opella.com/en/careers Show more Show less

Pharmacovigilance/ Sr Pharmacovigilance Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Roles & Responsibilities Review and process safety events (pre-marketing, post-marketing, medical device and drug) and/or other medically related information per assigned tasks and project specific procedures Perform review of abstracts and full articles to identify safety information from literature source for both pre and post marketed products. Generates data listings from the safety database and assumes responsibility for accuracy of the data. Complete adverse event follow-up in writing and/or by phone based on requirements for each Client. Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files* Perform safety review of clinical and diagnostic data as part of case processing. Responsible for effective and efficient development of the Safety Management Plan, including development of specific processes to assure consistency within the project. Support creation of post-marketing safety activities, such as PSMF, RMP and PBRER Support Qualified Person for Pharmacovigilance as required. Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues. Liaise with ICON Medical Monitor, project manager, and other departments, as appropriate. Assist with identifying out of scope activities in conjunction with the Pharmacovigilance Project lead (as applicable) Attend project team and Sponsor meetings and teleconferences as required including presentation of the safety process at kick-off and investigator meetings. Supports the generation of Aggregated Safety Reports (e.g. Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks. Supports interim data analysis for DMC reviews. Effectively maintains the safety database and corresponding entry guidelines, including assurance of quality of data following established quality control process. Supports creation of the SAE/AE reconciliation plan and supports SAE reconciliation in accordance with this plan and other project specific guidelines. Supports Safety Scientist in signal detection and risk management activities. Assures consistency of plans with client contract and identifies out of scope activities promptly and accurately. Proposes solutions for procedural and technical issues. Supports audits and inspections as required for the assigned projects. Perform other activities as identified and requested by management including but not limited to: Respond and process medical information inquiries including inquiries related to adverse events and product complaints for Clients’ product(s), as per their agreement with ICON. What You Will Be Doing Collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines. Conducting signal detection and risk assessment activities to identify potential safety issues. Collaborating with cross-functional teams to support safety-related inquiries and investigations. Maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices. Assisting in the preparation of safety reports and regulatory submissions. Your Profile Bachelor's degree in life sciences, pharmacy, or a related field; advanced degree preferred. Experience in pharmacovigilance, drug safety, or a related area, preferably within a clinical or pharmaceutical environment. Strong analytical skills with attention to detail in data collection and reporting. Excellent communication and interpersonal skills, enabling effective collaboration with team members and stakeholders. A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities. What ICON Can Offer You Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply Show more Show less

Key Accountabilities Technology Support Under supervision, conduct set-up and support activities associated with the Parexel safety database (and associated systems) including but not limited to new study set-up - Periodic report configuration and generation with oracle Analytics. Ad-hoc report configuration and generation with oracle Analytics. Expedited report rule configuration with oracle Analytics. End-user support. Provide support in the planning and delivery of the handover of the safety database from client to Parexel were contracted to take over the pharmacovigilance tasks for client projects. Provide support in the planning and delivery of the handover of safety data from Parexel to client at the end of study/project as contracted. Adhere to standard operating procedures and controlled documents that pertain to safety technology. Organizational Representation Interface with other Parexel groups (such as TQM, QA, IT) to ensure that database, hardware, network, security, quality, integration, support and project services associated with maintained systems are adequate and sufficiently managed. Support colleagues when working with external auditors and inspectors during the examination of safety technology. Issue Management Under supervision, collaborate with Parexel IT, vendor, Parexel Safety Services staff, and clients for the proper analysis, resolution, and closure of issues for supported systems. Team Support Provide support to new staff in the systems and activities necessary for the fulfillment of their job responsibilities. Change Management Under supervision, support change management in accordance with the Software Development Life Cycle. Under supervision, support execution of tasks for software updates, change requests and application support for the supported applications. Under supervision, support the implementation of technology solutions for Safety Services for the purposes of business process optimization and improvement. Ensure adherence to regulations concerning computer system validation, 21 CFR Part 11 compliance, procedures, and quality standards. Skills Good interpersonal, verbal, and written communication skills. Client focused approach to work. Good analytical and problem-solving skills. Good organizational and customer service skills. Willingness to work in a matrix environment and to value the importance of teamwork. Provide support to a team working through problem management. Under supervision, take ownership of core tasks related to the support and maintenance of safety technologies. Basic System Administration and application support skills within pharmacovigilance. safety technology, including at least one of: safety databases, gateway / E2B, report development, signal detection. Basic skills in using standard scripting languages e.g., SQL. Knowledge of industry standard Service Desk Tools. Basic technical writing capability. Knowledge of standard SDLC processes including change management. Knowledge of Agile methodology. A flexible attitude with respect to work assignments and new learning. Under supervision, complete multiple and varied tasks with enthusiasm and prioritize workload. Knowledge of system validation and change management. Basic knowledge of computer system regulations and guidance in the pharmaceutical industry including: 21 CFR Part 11, EMA Annex 11, GAMP. Basic knowledge of Pharmacovigilance roles, standards and practices. Basic knowledge of GVP and GCP. Education Bachelor’s degree in engineering/computer science, master's or equivalent preferred. Show more Show less

Job Overview Location - Kolkata only Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members. Essential Functions To Prioritize and complete the assigned trainings on time Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information determining initial/update status of incoming events database entry coding AE and Products, writing narratives, Literature related activities. Assuming other workflow responsibilities for the assigned project as directed by Operations team member or Manager. Ensure to meet the expected productivity and quality standards Ability to identify quality problems, if any, and bring them to the attention of a senior team member/ mentor. Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes. 100% compliance towards all people practices and processes Perform other duties as assigned Qualifications High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences An Individual with a minimum of a Bachelor’s Degree in scientific or healthcare discipline or allied life sciences graduation. Good knowledge of medical terminology. Strong verbal/written communication skills. Ability to work as a Team Player, contribute and work towards achieving Team goals. Good working knowledge of Microsoft Office and web-based applications. Self-motivated and flexible. Attention to detail and accuracy. Ability to follow instructions/guidelines, utilize initiative and work independently. Ability to manage competing priorities and deadlines. Willingness and aptitude to learn new skills across Safety service lines. Strong time management skills. Ensure quality of deliverables according to the agreed terms. Demonstration of IQVIA core values while doing daily tasks - Extensive use of keyboard requiring repetitive motion of fingers. Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Regular sitting for extended periods of time. May require occasional travel. Flexibility to operate in shifts. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com Show more Show less