410 Drug Safety Jobs - Page 10

Roles and Responsibility Conduct thorough medical reviews of patient records, including diagnoses, treatments, and test results. Analyze medical information to identify trends, patterns, and areas for improvement. Collaborate with healthcare professionals to develop and implement effective treatment plans. Maintain accurate and up-to-date records of patient information and review findings. Participate in quality improvement initiatives to enhance the quality of medical care. Develop and maintain knowledge of medical terminology, regulations, and standards. Job Requirements Strong understanding of medical terminology, anatomy, and physiology. Excellent analytical, communication, and problem-solving skills. Ability to work effectively in a fast-paced environment with multiple priorities. Proficiency in using electronic health records systems and other healthcare software. Strong attention to detail and ability to maintain confidentiality. Ability to work collaboratively as part of a multidisciplinary team.

Role & responsibilities Lead, mentor, and manage the Pharmacovigilance QA team to ensure effective execution of QA activities. Develop, implement, and maintain QA processes, procedures, and tools aligned with regulatory guidelines (e.g., ICH, FDA, EMA). Monitor and ensure compliance of pharmacovigilance activities with applicable regulations and internal SOPs. Conduct risk assessments and develop mitigation plans to ensure PV compliance . Oversee the management and closure of CAPAs (Corrective and Preventive Actions) following audits or inspections. Plan, coordinate, and conduct internal and external audits of PV processes, systems, and vendors audits ( Risk Based Audit approach ). Lead audit preparedness activities and ensure timely resolution of audit findings. Collaborate with cross-functional teams to implement audit recommendations and continuous improvements. Maintain audit documentation and track audit metrics for management review. Ensure all QA activities support compliance with global pharmacovigilance regulations, including GVP (Good Pharmacovigilance Practices). Participate in regulatory inspections and provide QA support as needed. Review and approve quality documentation related to PV activities such as SOPs, training materials, and audit reports. Identify QA training needs for the PV team and develop training programs accordingly. Conduct and coordinate training sessions on quality standards, SOPs, and compliance requirements. Promote a quality culture and awareness within the PV department. Identify gaps and areas for improvement within PV and QA processes and implement best practices. Collaborate with PV operations and other departments to optimize workflows and enhance quality outcomes. Utilize metrics and KPIs to monitor quality performance and drive continuous improvement. Act as the key liaison between PV, QA, regulatory affairs, and other stakeholders. Provide guidance and support on quality-related matters to internal teams and external vendors. Facilitate effective communication to ensure alignment on quality expectations and deliverables. Plan, assign, and review work for QA team members and provide ongoing feedback and development opportunities. Facilitate team meetings and promote continuous communication and knowledge sharing within the team. Support recruitment, onboarding, and performance management of QA staff. Preferred candidate profile Bachelors degree in Pharmacy, Life Sciences, or related field (Master’s preferred). Extensive experience (typically 7+ years) in Pharmacovigilance with significant exposure to QA activities. Strong knowledge of global pharmacovigilance regulations, GVP, and quality management systems. Proven leadership and team management skills. Experience in conducting audits and managing CAPAs . Excellent communication, organizational, and problem-solving skills. Ability to work collaboratively with cross-functional teams and external vendors.

Role Regional Managing Partner - Deputy Vice President, Kotak Agency - Field Sales (L7) Experience 6-12yrs. Job Role Recruitment Parameters -Increasing Distribution through Coding of new Partners & increasing LA base -Pragati Promotion -SAP / CAP Creation -Partner Promotion -Handhold & Coach Distribution for Recruitment -Minimum Distribution Criteria of 8:80 Business Parameters -Meet the budgeted business numbers -Maintain minimum Persistency of 85% -Coach & Train Agency to work Independently & Digitally -Meet the CLA numbers -Initiatives to improve Partner Income -Periodic meeting of Partners & Las -Support Agency with all relevant report & MIS Primary Responsibilities External Relations Internal Relations Educational qualifications preferred Category Bachelor's Degree

SUMMARY Job Title: SAR & SAR-like Patient Safety Physician Reporting To: Patient Safety Physician SAR & SAR-like Coordinator Minimum Educational Qualifications and Experience Required Skills 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 Operational Responsibilities Compile PBRERs with a focus on medical aspects and safety sections of products, and analyze safety trends, including source data analysis based on queries Assist in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborate with Therapeutic Head to identify signals and address product safety concerns Engage with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensure 100% compliance with timely completion of all client and Cognizant required trainings Achieve 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 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

6 montt to 1 year for pharmacist 1 to 2 year for non pharmacist Dispense prescription and over-the-counter medications accurately Provide appropriate medication counseling and drug usage instructions Maintain proper storage mngt Required Candidate profile Check prescriptions for accuracy and possible drug interactions Ensure compliance with medical and pharmacy regulations Maintain pharmacy records as per statutory requirements

KEY RESPONSIBILITIES Prescription Fulfilment Stock Management & Substitution Patient Counseling Delivery Coordination Customer Support & Inquiries Cash Handling Proper Storage & Security Inventory Verification Provident fund Annual bonus

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: MBBS/MD Years of Experience: 3 to 5 years Language - Ability: English(International) - Proficient About Accenture 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 worlds 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. Visit us at www.accenture.com What would you do Performs Medical Assessment activities related to drug safety Pharmacovigilance for the Individual Case Safety Reports- Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals- Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP- Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables- Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable- Performs labelling of events of applicable cases- Provides Medical Expertise to case processing team whenever required- Provides training/mentoring to the team members wherever applicableCreate 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 Understanding of PharmacovigialnceExperience in Medical Review of ICSRsMedical Review Roles and Responsibilities: - Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals- Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP- Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables- Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable- Performs labelling of events of applicable cases- Provides Medical Expertise to case processing team whenever required- Provides training/mentoring to the team members wherever applicable Qualification MBBS,MD

Works with a team of Medical regulatory writers with different levels of expertise, Develops medical expertise within Medical regulatory writing (on contents, methods, and processes). Ensures compliance with regulatory requirements from various regions (FDA, EU others) for activities supported. Coordinates and supports medical activities related to the maintenance of the marketing authorizations of Established and Generic products, in different therapeutic areas. Works in close collaboration with Global Medical Leads, Global Regulatory Affairs, Global Pharmacovigilance, and vendors Essential Job duties and responsibilities: Responsible to provide a medical assessment with relevant and updated clinical evidence and monitoring the execution of strategic documents such as PBRERs, ACOs, DSURs, Clinical Overviews, Benefit-Risk assessments, Expert statements for MDD, Responses to Health Authority Queries, Ad-hoc literature analyses, and labeling documents for the corresponding therapeutic area or products or any other activities which are the core activities of GMLs. Drafting the extended synopsis of studies in collaboration with RWE experts. He/she will be responsible for overseeing the execution of such plans by the respective operational units in compliance with SOP, GCP, and other regulations. Writing of Key medical/clinical parts of Common Technical Documents (CTD) or Briefing packages (BP). Reviewing and approving compassionate use of individual medical requests for use of Sanofi medicinal products for serious or life-threatening diseases for treatment outside of clinical trials. Secure delivery of high-quality medical documents on time and in compliance with internal and external standards. Collaborates effectively with stakeholders: global medical leads/ medical product leads, global regulatory affairs, medical regulatory writing global or local teams, pharmacovigilance teams, managed access program teams. People: Maintain effective relationships with the end stakeholders (Medical, regulatory, pharmacovigilance community) within the allocated Global business unit and product with an end objective to develop medical regulatory content as per requirement, 2) Interact effectively with stakeholders in medical and pharmacovigilance departments 3) Constantly assist the medical regulatory writing team in developing knowledge and sharing expertise Performance: Secure deliverables (PBRER, ACO, SO, CSR, ID Cards, Investigator brochure, clinical evaluation report, briefing packages, medical section of CTA, CTD, SBRAs, MDD, HAQs or any other activities which are core activities for GMLs) are supported as per agreed timelines and quality Process: Provide medical strategic insights & evaluation related to Company's portfolio. Contribute to the management of the marketing authorization dossiers of the current related portfolio. Act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries, and teams supported. Assist the assigned medical team in conducting comprehensive medical regulatory writing-needs analysis Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region Work with selected vendors when required within the region to deliver the required deliverables as per the defined process Assist the head of scientific communications in designing an overall plan of action based on end-customers feedback & improving course content and delivery. Stakeholders : Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables Liaise with the Medical department to ensure relevant & customized are delivered per expectation About you Experience : 5 years of experience supporting international pharmaceutical companies: medical affairs, clinical development, pharmacovigilance with experience in at least one of the therapeutic areas- cardiovascular, metabolism, diabetes and lipid, CNS, oncology, anti-infectives, internal medicine Soft skills : Stakeholder management; communication skills; and ability to work independently and within a team environment Technical skills : As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, Excellent technical (medical) editing and writing skills) Education : Medical degree MBBS; MD Languages : Excellent knowledge of the English language (spoken and written)

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Purpose: Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products Provide medical guidance and input to Drug Safety Associates (DSAs) and specialists in medical aspects of drug safety Function as pharmacovigilance representative/safety scientist General Maintaining a good working knowledge of the Adverse event profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and international drug safety regulations Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting Maintaining excellent knowledge of the safety profile of assigned products Communicating and discussing issues related to review process with Project Manager Interacting with internal and external contacts for resolving issues Maintaining a good working knowledge of relevant regulatory guidelines Attend and present client/cross functional meetings along with other stakeholders Training and mentoring new team member, as required Working as Subject Matter Experts (SMEs) Assisting the Manager for inspection readiness activities and audits Provides inputs for process improvisations Works closely with Manger for process co-ordination and to ensure meeting all KPIs for the process. Case report Medical review (as applicable) Performing medical review of cases according to client Standard Operating Procedures (SOPs) and liaising with the client, as required Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality Assessing seriousness and expectedness of reported events Providing medical advice to DSPs and case processing team Skills: Excellent interpersonal, verbal and written communication skills Computer proficiency, an ability to work with web-based applications and familiarity with the Windows operating system Client focused approach to work A flexible attitude with respect to work assignments and new learnings Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential Willingness to work in a matrix environment and to value the importance of teamwork Strong knowledge of international drug regulation including GCP, GVP Knowledge and Experience: Relevant experience of minimum 2 Years in Pharmacovigilance/ drug safety is desirable. Education: MBBS/Post Graduation in Medicine.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Title: Safety Data Exchange Agreement (SDEA) Drug Safety Specialist Job Summary: The SDEA Pharmacovigilance (PV) Specialist is responsible for managing Safety Data Exchange Agreements between the company and its partners in the contract management database, ensuring compliance with global pharmacovigilance regulations and facilitating efficient exchange of safety information, coordinating with various stakeholders, manage the lifecycle of SDEAs/PVAs for business relationships ensuring to meet the standard process and applicable regulatory requirements. Responsible to assess contractual information related to PV obligations on different type of reports like individual case safety reports, aggregate reports, signal reports, literature screening and other PV related aspects. Key Responsibilities : Management of Global and Local SDEAs (SDEA / PV clause / Pharmacovigilance Agreement / Vigilance Agreement, PV Agreement for Clinical Supply, Divestments) for investigational, post marketing, marketed products, vaccines and medical devices. Review and assessment of PV obligations from contracts on different type of reports ICSR processing and timelines, PSURs/PBRERs, RMPs, Signal detection, Clinical study reports, periodic line listings, literature screening, labeling etc. to ensure accurate information is entered in the database. Management of Safety database related configuration requests and updates. Build and manage reports (Business Partner lists) periodically from the Contract management database to provide the operational functions with the latest contacts list for implementation in their processes or systems Maintain a database of all agreements and track their status, expiration dates, and amendments. Provide guidance on SDEA-related issues to stakeholders and non-stakeholders. Ensure timely execution of SDEAs in the database to support project timelines. Strict adherence to the standard operating procedures (SOPs) and guidelines. Ensure all executed PVAs and its Main agreements are tracked within Global Comprehensive tracker and filed within dedicated share folder. Provide support in ad-hoc activities to support the periodic aggregate teams for preparation of PSURs/DSURs Efficient in mailbox management and reconciliations. Conduct training sessions on SDEA processes and requirements for relevant staff. Perform Quality check on the processed data entries. Monitoring of Key performance indicators (KPIs) and metrics. Stay current with global pharmacovigilance regulations and industry best practices. Participate in audits and inspections related to safety data exchange processes. Qualifications: Bachelor's degree in Life Sciences, Pharmacy, or a related field. Advanced degree preferred. 2-3 years of experience in pharmacovigilance, clinical research, or a related field. Knowledge and Experience : Related experience in drug safety/ pharmacovigilance and contract (SDEA/PVA) management is desirable Strong knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH, EMA, FDA). Strong knowledge of pharmacovigilance terminologies on Individual case safety reports, Aggregate safety reports, Signal and risk management, and related regulations and guidelines (e.g., ICH, EMA, FDA). Strong knowledge about the master service agreements and terminologies. Experience in management of the ICSRs in safety database. Understanding of medical terminology and adverse event coding. Experience in automation / artificial intelligence would be an asset. Desired Skills: Sound knowledge of drug safety, data analysis and evaluation of safety data Ability to work collaboratively and effectively in a team environment Client focused approach to work Ability to evaluate data and draw conclusions independently Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Computer proficiency, IT skills, the expertise and ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)

The Clinical Trial Physician is responsible for providing medical input within the organization as well as to external partners and performing medical review tasks within the context of clinical trials. Furthermore, the Clinical Trial Physician is responsible for undertaking scientific/medical writing tasks within the organization. Role & responsibilities Is responsible for the development of: All study related documents that fall under the Clinical Science Department scope (e.g., Study Protocols, ICFs - in collaboration with other departments e.g., Clinical Operations, Regulatory, as required -, Pharmacy Manuals, Medical Review Plans, etc.), Scientific presentations and manuscripts, Medical training material (i.e. therapeutic area and study protocol training material) Delivers internal and external study protocol and therapeutic area training courses Provides medical expertise and consultation within the Company on key therapeutic areas of the clinical development program Provides guidance to all involved departments on the medical and scientific aspects of the assigned clinical trials/projects. Responds to medical queries from all involved parties in assigned clinical trials (e.g., CRAs, Project Managers, Clinical Operations Managers, Investigators) and collaborates with all concerned staff in maintaining an up-to-date study-specific Q&A log Is available 24/7 to respond to urgent medical/protocol related issues derived from an Investigational Site, as applicable Performs periodic medical review of the data from clinical trials according to the study-specific Medical Review Plan requirements (e.g., review of eligibility, review of efficacy and safety data). Performs real-time medical review on urgent medical and safety issues, as needed Collaborates with and provides medical input to the Data Management staff to ensure the successful development of the study-specific eCRF Attends Investigator Meetings and Conferences, as applicable Complies with the Company's Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection and ICH GCP requirements Preferred candidate profile Required Medical Degree (MBBS, MD) Preferred: Clinical experience in the therapeutic area of the assigned study or of the Companys clinical development program - Preferred: 2 years of experience in a CRO or in the pharma industry in a relevant role (Clinical, Medical Information, Medical Affairs or PV) Key competencies Exceptional written and oral use of English In-depth knowledge of medical and drug terminology Good medical judgement and ability to make medical decisions Excellent communication skills Excellent business acumen Initiative taking and team working attitude Excellent Organizational skills Innovative thinking Excellent IT skills Deep understanding of the Clinical Development industry

*Greetings From You & I Consulting ! You & I Consulting has always been in the spotlight for getting placed in 64+ MNC's PAN India. *Hurry Do Not Miss This Opportunity To Work For Global Giant MNC. We are hiring for the below locations under Medical Reviewer Role!! *Open Locations :- * Pune/ / Chennai / Mumbai *Mode Of Interview - Virtual *Mode Of Work :- Work From Office * CTC Upto - 10 To 24Lpa *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) or email your CV to puja@careersuni.com PFB Job Insights for Medical Reviewer Role!! Author a CCC for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. Detail any requests for changes to the case, including the narrative. Skills required:- Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills * * *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com ***Note we also have open positions for the below skills :- * * *Call Now our HR Specialist for more details:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com *Aggregate Reporting / Clinical Data Management / Clinical SAS / SQL Programmer / EDC Programmer / Medical Monitor / HEOR Health Economist Role / SAS + R / Statistical Programmer / Study Data Manager *Though We Try and Answer The Calls Immediately, but Due to Heavy Call Flow The Below Numbers Might Be Busy At Times. In case you find the number busy, please whatsapp your details to us in the below format: - Name- Mobile number - Mail - Qualification - Total work experience - Current Organization- Location - Last CTC Expected CTC:- *Interested candidates can even refer their friends or relatives provided the criteria *FOR interview Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture 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 worlds 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. 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 worlds 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 Affiliate Team AssociateAffiliate Team Associate 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 Qualification Bachelor of Pharmacy,Master of Pharmacy

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: BSc/Bachelor of Pharmacy Years of Experience: 0 to 1 years Language - Ability: English(International) - Proficient About Accenture 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 worlds 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. 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 worlds 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 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. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines. 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. 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 Qualification BSc,Bachelor of Pharmacy

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 years Language - Ability: English(International) - Advanced About Accenture 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 worlds 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. Visit us at www.accenture.com What would you do 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.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.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. What are we looking for 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.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. 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 Qualification Bachelor of Pharmacy

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Sr Analyst Qualifications: Bachelor of Pharmacy Years of Experience: 5 to 8 years About Accenture 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 worlds 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. 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 worlds 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.In this role, you will be expected to 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 Ability to establish strong client relationshipAbility to work well in a teamCollaboration and interpersonal skills Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy

Watson Pharma Private Limited. is looking for Medical Writing Associate to join our dynamic team and embark on a rewarding career journey Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Preparation of operating budgets, financial statements, and reports. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processe

Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Associate Qualifications: BCom/MCom/Master of Business Administration Years of Experience: 1 to 3 years About Accenture 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 worlds 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. Visit us at www.accenture.com What would you do We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model.The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whilst safeguarding the bank from risks associated with this business.Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for Adaptable and flexibleAbility to perform under pressureAgility for quick learningAbility to work well in a teamCommitment to quality 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 Qualification BCom,MCom,Master of Business Administration

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The SMW will be responsible for authoring the signal management reports including Validations, SERs, HA requests etc. The scientist will support early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development and marketed portfolio. In the post-market setting this may include and may include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management Perform signal detection review and analysis (qualitative and quantitative) from various sources e.g. regulatory authority database, client database, literatures, regulatory authority websites etc. Responsible for the end-to-end signal management process (i.e. signal tracking, signal assessment/data analysis, leading review meetings, presenting, etc.) in collaboration with the GSO. Conduct/support signal detection and evaluation activities according to SOPs and guidelines Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, procedures and SOPs, and international drug safety regulations Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for the adverse event reporting Maintaining a good working knowledge of the assigned Clinical studies for narratives Attending/conducting internal, drug safety and project specific training sessions Imparting trainings to the new starts during the induction sessions and the team as required. Skills: Analytical and problem-solving skills Excellent interpersonal skills Excellent verbal / written communication skills Excellent organizational and prioritization skills Ability to work collaboratively and effectively in a team environment Client focused approach to work Ability to evaluate data and draw conclusions independently A flexible attitude with respect to work assignments and new learning Ability to negotiate on behalf of the department to ensure resources, timelines and expectations are aligned Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Fluency in written and spoken English Computer proficiency, IT skills, the expertise and an ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point) Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Provides departmental expertise and perspectives to promote prospective business opportunities. Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text Typing and transcription accuracy Knowledge and Experience : Relevant experience is desirable in Regulatory/ Pharmacovigilance or related field. Good knowledge of medical terminologies Education: Science/Medicine degree: The minimum qualification required would be a university degree in life Sciences/Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.) A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Purpose: Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products Signal detection/analysis/evaluation and ongoing safety surveillance activities Provide medical guidance and input to Drug Safety associates (DSAs) and specialists in medical aspects of drug safety Function as pharmacovigilance representative/safety scientist General Maintaining a good working knowledge of the Adverse event profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and international drug safety regulations Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting Maintaining excellent knowledge of the safety profile of assigned products Communicating and discussing issues related to review process with Project Manager Interacting with internal and external contacts for resolving issues Maintaining a good working knowledge of relevant regulatory guidelines Attend and present client/cross functional meetings along with other stakeholders Case report Medical review Performing medical review of cases according to client Standard Operating Procedures (SOPs) and liaising with the client, as required Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality Assessing seriousness and expectedness of reported events Providing medical advice to case processing team Skills: Excellent interpersonal, verbal and written communication skills Computer proficiency, an ability to work with web-based applications and familiarity with the Windows operating system Client focused approach to work A flexible attitude with respect to work assignments and new learnings Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential Willingness to work in a matrix environment and to value the importance of teamwork Strong knowledge of international drug regulation including GCP, GVP Knowledge and Experience : Good knowledge of medical terminology. Fresher/ relevant experience into pharmacovigilance/ Drug Safety field is preferred. Education: MBBS/MD

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

Key Responsibilities: Safety Signal Detection and Triage: Perform safety signal detection and triage activities for a challenging product portfolio. Identify new safety signals based on review and comprehensive medical evaluation of technical hits in post-marketing spontaneous reporting databases, analyzing single case reports as well as aggregate data available. Expert Evaluation: Provide expert evaluation of results of post-marketing signal detection activities at cross-functional team meetings, including Safety Review Meetings and Joint Safety Committees as appropriate. Collaboration: Collaborate productively with the safety leads for the respective products. Serve as a core member of the cross-functional Signal Management Team, providing expert input for post-marketing signal detection activities using internal and external spontaneous reporting databases. Database Searches and Analysis: Perform database searches in external Health Authority databases (FAERS, Vigibase, iDAP, DAEN), analyzing and reporting the results. Perform QC checks of Health Authority database searches done by colleagues. EudraVigilance Management: Manage EudraVigilance database requests, including monitoring EudraVigilance for assigned products. Provide support in training and mentoring junior Safety Signal Colleagues. Development of Guidance Documents: Drive the development and update of Business Guidance documents and SOPs. Contribute to the development of new approaches for automated signal detection in internal/external databases Qualifications: Bachelors degree in a relevant scientific or medical field (e.g., Pharmacology, Medicine, Life Sciences). Advanced degree preferred. Experience in pharmacovigilance, drug safety, or related field, with a focus on safety signal detection and triage. Knowledge of post-marketing spontaneous reporting databases and Health Authority databases (FAERS, Vigibase, iDAP, DAEN). Strong analytical and problem-solving skills with the ability to evaluate and interpret complex safety data. Demonstrated ability to collaborate effectively with cross-functional teams and provide expert input in a matrix environment. Experience in managing EudraVigilance database requests and conducting QC checks of database searches. Strong organizational skills with the ability to manage multiple tasks and projects simultaneously. Excellent written and verbal communication skills. Proficiency in developing and updating SOPs and Business Guidance documents.

Job Description Java Technical Lead About ArisGlobal: (www.arisglobal.com): ArisGlobal is empowering life science organizations to deliver breakthroughs faster, accurately, and with precision. This is paramount for the passage of lifesaving medications and products VIA clinical trials, using our software and technology. As an industry leader, ArisGlobal provides our SaaS leading technology and services to 40/50 top Bio-pharmaceutical corporations, 4/5 of the most advanced global pharmaceutical companies and nine government-health authorities, including the FDA, Health Canada and the NMPA, for example, around the world. 2021 has presented simultaneous developments in the global Drug Safety and Pharmacovigilance Software Market, projecting unfaltering growth through 2027. Effectively harnessed by prominent market drivers, ArisGlobal is named a Key Player. Located in Miami, New Jersey, Budapest, Dublin, Darmstadt, Rome, Tokyo, Shanghai, Bangalore, Mysore, our global presence is clear, and we are growing faster than ever. Skills & Experience Required: Candidate should have 4 to 6 Years of hands-on Java Programming experience Should have experience in Java, J2EE, Spring, Hibernate, SQL/MySQL & Microservices Minimum 2+ Years of hands-on experience in React Js (Mandatory) Should have worked on Apache Kafka, Mongo DB & AWS Should have experience in Leading/Mentoring team Key Responsibilities : Execute the design, analysis, or evaluation of assigned projects using sound engineering principles and adhering to business standards, practices, procedures, and product / program requirements Design & code a variety of complex software features with adequate documentation Customer Support & troubleshoot/fix a variety of difficult software problems. Proactively communicate on development status & delays in agreed upon timelines Interface with global teams for requirements analysis and schedule.

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

Role & responsibilities Responsible for daily case processing of adverse event cases (clinical trial and/or post marketed), including coding using MedDRA, determining seriousness and expectedness at the event and case level. Perform case follow up activities such as identification of information to be collected during follow-up. Creating and reviewing case narratives. Providing client notifications as required for case management. Case downloading from regulatory authority websites Submission to applicable regulatory authorities within stipulated timelines Supporting and contributing to the development of training materials and training delivery. Highlight areas of concern/discrepancies to the Principal PV Specialist, Case Processing and/or Manager, Case Processing when related to ICSRs. Acquire and maintain an up-to-date knowledge of global safety regulations for medicines. Peer reviews of cases for quality, consistency, and accuracy as needed. Other duties as assigned Preferred candidate profile Strong verbal, written and interpersonal communication skills. High level of accuracy and attention to detail. Excellent organization and prioritization skills; able to multitask. Basic knowledge of Pharmacovigilance. Interested applicants can also apply directly with updated CV to hr@qpsbioserve.com