1738 Pharmacovigilance Jobs - Page 15

As a Pharmacovigilance Services Associate at Accenture, you will be responsible for supporting Pharmacovigilance Operations, focusing on drug safety surveillance. With a qualification of Bachelor of Pharmacy or Master of Pharmacy and 1 to 3 years of experience, you will play a crucial role in the management of the Affiliate Mailbox, reconciliation of reports, and conducting follow-up activities for both Serious and Non-serious cases. Your responsibilities will include case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for Individual Case Safety Reports (ICSRs) in the safety database as per client guidelines and global regulatory requirements. Aligned with Accenture's Life Sciences R&D vertical, you will be part of a team that provides services across the life sciences enterprise, supporting research laboratories, clinical trials, regulatory services, pharmacovigilance, and patient solutions. By collaborating with leading biopharma companies, you will contribute to improving outcomes by focusing on patient-centric approaches and leveraging scientific expertise to enhance patient experiences. In this role, you will solve routine problems with guidance from general guidelines and precedents. Your interactions will primarily be within your team and direct supervisor, and you will receive detailed instructions for daily tasks and new assignments. Your decisions will impact your own work as you work as an individual contributor within a focused scope of work. Please note that this position may require you to work in rotational shifts. If you are a detail-oriented individual with a background in pharmacovigilance and a passion for drug safety, this role offers an opportunity to contribute to the advancement of healthcare through the convergence of technology and human ingenuity. Join Accenture in delivering on the promise of technology and creating shared success for clients, partners, and communities worldwide.,

As a Medical Safety Expert, your primary responsibility will be to provide medical safety expertise to Sponsors of drugs, devices, and combination products during the post marketing period. This will involve undertaking the primary medical review of cases, including assessing seriousness, listed/labeling, causality, adverse event coding, and narrative review. You will be required to update and document case data daily, provide training and guidance to the case processing team on medical aspects, and ensure all assigned deliverables meet quality, compliance, and productivity standards. Additionally, you will perform secondary medical reviews and retrospective reviews to measure the quality of deliverables, identify error trends, and contribute to process improvement activities. Your role may also involve aggregate medical review and signal detection/analysis activities. It is essential to maintain client relationships, promote a culture of high customer service, and participate in enhancing processes across the company. To qualify for this position, you must hold a Bachelor's degree in medical science, MD, DO, or equivalent. Relevant experience may be considered in lieu of educational requirements. Proficiency in English at ILR level 3+ for speaking and level 4+ for writing/reading is required. You should have a working knowledge of medical sciences, diagnosis, therapeutics, drug treatments, regulatory requirements for Clinical Research, and ICH-GCP guidelines. Preferred qualifications include a good understanding of regulatory requirements related to Pharmacovigilance and up to 2 years of experience in the pharmaceutical industry, particularly in pharmacovigilance or clinical research. Clinical practice experience of 1 to 2 years is also preferred. This role may involve working in an office or home-based environment as requested by the line manager. Your dedication to ensuring high-quality deliverables, maintaining strong client relationships, and contributing to process improvements will be key to your success in this role.,

The Global Safety Officer (GSO) for Marketed Products plays a crucial role in ensuring the safety and well-being of the assigned marketed products. As a GSO, you will be responsible for establishing the strategy, direction, and priorities of pharmacovigilance activities related to the assigned products. Your accountability extends to overseeing the overall safety profile, making product-related decisions, and delivering on all associated responsibilities. Leading the Safety Analysis Team (SAT), Global Safety Team (GST), and serving as a core member of the Executive Safety Committee (ESC), you will be an integral part of the safety governance structure. Additionally, as a member of the Evidence Generation Team, you will contribute to the evidence generation process. When necessary, you may act as a delegate for the TAH and manage Global Safety Scientists. Your key activities will involve various tasks depending on the assigned product(s). These activities include but are not limited to: - Developing and maintaining core reference safety information - Conducting benefit-risk evaluations - Participating in the product label process - Developing strategies for clinical trial safety - Leading responses to safety-related inquiries from regulatory agencies - Performing signal detection activities - Evaluating safety signals and determining further analysis strategies - Developing risk management plans - Ensuring timely preparation of periodic safety reports - Participating in safety governance meetings - Representing Global Patient Safety in commercialization processes - Undertaking activities for inspection readiness - Participating in safety agreement development and review process - Interacting with external stakeholders on safety-related topics - Providing safety input to support legal needs - Overseeing day-to-day activities of the Global Safety Physician (if applicable) - Providing training, coaching, mentoring, and development of staff - Assisting in the recruitment of talented personnel - Disseminating and representing corporate and departmental information to staff The ideal candidate for this position should hold a Medical Degree (MBBS or MD) from an accredited medical school and have a minimum of 8 years of relevant experience in product safety within the bio/pharmaceutical industry, CRO, or regulatory agency. Previous management and/or mentoring experience, as well as clinical/medical research experience, are preferred qualifications.,

Job * Engineering & Maintenance Management pharma machine installation,qualifiaction as per cGMP * Ensure compliance with regulatory standards during production, * Oversee CAD drawing creation using AutoCAD software .c ompliance & Validation Office cab/shuttle Maternity benefits in mediclaim policy Health insurance Employee state insurance Maternity policy Military leave policy Annual bonus

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.

Job Overview Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period. Summary Of Responsibilities Undertake primary medical review of cases, including medical assessment of the case for seriousness, listedness/labeling, causality, adverse event coding and narrative review. Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management. Assume complete responsibility for all assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs. Provide training and guidance to the case processing team on medical aspects of case processing, only after a tenure of 1 year. Performs secondary medical review (QC role) and retrospective review of cases reviewed (QA role), as required for measuring quality of deliverables, identifying error trends, training needs and areas of improvement only after a tenure of greater than 1year. Performs aggregate medical review and signal detection/analysis activities, as required. Enhances existing client relationships whenever possible. Creates, maintains, and assumes accountability for a culture of high customer service. Participates in process improvement activities across Company. Qualifications (Minimum Required) Bachelor’s degree in medical science or MD or DO or equivalent degree. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Language Skills: Speaking: English at ILR level 3+ or higher. Writing / Reading: English at ILR level 4+ or higher. Experience (Minimum Required) Working knowledge of medical sciences, diagnosis and therapeutics including drug treatments and procedures. Knowledge and understanding of regulatory requirements for Clinical Research. Knowledge and understanding of ICH-GCP guidelines. Preferred Qualifications Include Good understanding of regulatory requirements relating to Pharmacovigilance. Up to 1 year of pharmaceutical industry experience, including pharmacovigilance (case processing, medical review) and / clinical research. 1 to 2 years of Clinical practice experience. Physical Demands/Work Environment Office or home-based environment, as requested by the line manager. Learn more about our EEO & Accommodations request here.

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.

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 Safety Scientist to join our diverse and dynamic team. As a Safety Scientist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of inNvative treatments and therapies. What You Will Be Doing Conducting safety surveillance activities for assigned projects, including the review and interpretation of safety data. Partnership with cross-functional teams to ensure the safety of study participants and compliance with regulatory requirements. Contributing to the development and implementation of safety management plans and risk minimization strategies. Participating in safety review meetings and providing expert input on safety-related matters. Contributing to the preparation of safety-related documents for regulatory submissions and responses to regulatory queries. Oversees operational activities as the functional PV team lead. Assist project teams in client meetings when pharmacovigilance, safety surveillance, risk management which require expert knowledge beyond the expertise of Drug Safety Associates are discussed Support literature search and review projects by: Authoring literature search and review plans for routine pharmacovigilance, local literature, aggregate safety analysis, EMA Medical Literature Monitoring Defining search parameters (string terms) Conducting literature search and review as per project-specific plan Under the Guidance of a Director, Pharmacovigilance specialized services and/or Senior Principal/ Principal safety scientist, the safety scientist is responsible for: Aggregate safety report generation Coordinate aggregate safety report generation, including data collection, data and document querying, coordination of internal and external reviews, and interfacing with the Client and Safety Writers. Generate and maintain aggregate safety report plans including generation of data specifications and literature search requirements. Author where necessary or review aggregate safety report drafts, including Sponsor authored drafts where ICON is legal representative Safety surveillance activities Coordinate and document the signal detection strategy Draft required plans and forms Manage and organize the source data Participate in development and generation of the data assessment visuals and tables in ICON visualization tool. Review interval and cumulative data as per safety surveillance plan Document and track all signal management activities Generate and / or Review signal detection reports, signal validation reports and signal assessment reports Organizes and coordinates internal and external meetings regarding signal management, including drafting of minutes Draft safety section of product reference documents (e.g. IB/ reference safety information, CCDS/CCSI, local labeling). Review of safety sections of a protocol, Review safety listings, review of ICSRs Generation of development risk management plans (dRMP), risk management plans (RMP), and risk evaluation and mitigation strategies (REMS) Coordinate risk management document generation, including data collection, data and document querying, coordination of internal and external reviews, and interfacing with the Client and Safety Writers. Track initial RMP filing and subsequent updates Support risk management SMEs on appropriate strategy and design of risk management activities and risk minimization measures. Perform implementation, tracking and communication of risk management commitments including risk minimization measures Contribute to generation and maintenance of: Pharmacovigilance system master files (PSMF) and associated project plans. Pharmacovigilance agreements and associated project plans Other activities: Assist with the maintenance of key performance indicators (KPIs) and compliance metrics. Assist in preparation of audits and inspections. Participate in ICON initiatives for the implementation and integration of new or enhanced: Process development or maintenance (SOPs, WPs, templates, best practices) Systems, databases and tools Development and/or delivery of training courses on pharmacovigilance related topics to ICON Your profile Bachelor's degree in life sciences, pharmacy, or related field; advanced degree preferred. Solid experience in pharmacovigilance or drug safety within the pharmaceutical or clinical research industry. Strong understanding of pharmacovigilance principles, regulations, and guidelines. Excellent analytical and critical thinking skills, with the ability to interpret complex medical data. Effective communication skills, with the ability to cooperate effectively with cross-functional teams. Detail-oriented and able to work effectively in a fast-paced environment with changing priorities. 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

Credit Assessment, Risk Management, Loan Approval Process : Evaluate loan applications and creditworthiness of applicants based on financial data and other relevant factors. Perform detailed analysis of financial statements, bank statements, and credit reports. Assess repayment capacity and recommend appropriate loan structures. Identify, analyze, and mitigate potential credit risks. Ensure compliance with internal credit policies and regulatory guidelines. Conduct periodic portfolio reviews to identify early warning signals. Coordinate with sales and operations teams for smooth processing of loan applications. Approve or recommend loans within delegated authority limits. Liaise with legal and technical team for finalization.

Credit Assessment, Risk Management, Loan Approval Process : Evaluate loan applications and creditworthiness of applicants based on financial data and other relevant factors. Perform detailed analysis of financial statements, bank statements, and credit reports. Assess repayment capacity and recommend appropriate loan structures. Identify, analyze, and mitigate potential credit risks. Ensure compliance with internal credit policies and regulatory guidelines. Conduct periodic portfolio reviews to identify early warning signals. Coordinate with sales and operations teams for smooth processing of loan applications. Approve or recommend loans within delegated authority limits. Liaise with legal and technical team for finalization.

Credit Assessment, Risk Management, Loan Approval Process : Evaluate loan applications and creditworthiness of applicants based on financial data and other relevant factors. Perform detailed analysis of financial statements, bank statements, and credit reports. Assess repayment capacity and recommend appropriate loan structures. Identify, analyze, and mitigate potential credit risks. Ensure compliance with internal credit policies and regulatory guidelines. Conduct periodic portfolio reviews to identify early warning signals. Coordinate with sales and operations teams for smooth processing of loan applications. Approve or recommend loans within delegated authority limits. Liaise with legal and technical team for finalization.

Job Summary We are looking for a motivated and detail-oriented Clinical Audit Coordinator to support our Regulatory Quality & Compliance team. This is an ideal opportunity for recent graduates in Pharmacy, Clinical Research, Pharmacology, or Life Sciences to begin a career in clinical quality and regulatory audits. The role focuses on supporting audits conducted under GxP frameworks, including GCP, GLP, and GVP. ⸻ Key Responsibilities • Assist in planning, scheduling, and coordinating regulatory audits (GCP/GLP/GVP), including internal, external, sponsor, and regulatory inspections. • Support pre-audit document collection and preparation, including clinical trial documentation, SOPs, and training logs. • Help prepare audit materials: audit agendas, logistics checklists, and audit team communications. • Maintain and update audit trackers, audit logs, and regulatory compliance records. • Communicate effectively with cross-functional teams (clinical, pharmacovigilance, regulatory affairs, quality) to ensure timely responses and document submissions. • Assist in drafting audit summary reports, documenting findings, and tracking Corrective and Preventive Actions (CAPAs). • Support document archival and ensure adherence to ALCOA+ principles for data integrity. • Stay informed of evolving global regulatory requirements related to GCP, GLP, GVP, and data privacy (e.g., ICH, FDA, EMA, CDSCO). ⸻ Required Qualifications & Skills • Bachelor’s degree in Pharmacy, Life Sciences, Pharmacology, or Clinical Research. • Strong communication (written and verbal) and organizational skills. • Basic understanding of clinical trial processes, regulatory frameworks, and GxP principles. • Proficiency in Microsoft Office (Word, Excel, Outlook); exposure to quality or document management systems is a plus. • Strong attention to detail and ability to follow procedures with discipline and accuracy. ⸻ Preferred Attributes • Eagerness to learn and grow in clinical quality and regulatory compliance roles. • Exposure to GCP/GLP/GVP principles during coursework or internships is an added advantage. • Ability to handle confidential information responsibly and ethically. • A team player with a strong work ethic, problem-solving mindset, and adaptability in a fast-paced environment. ⸻ Benefits • Structured training in clinical quality and regulatory compliance. • Mentorship from experienced audit and quality professionals. • Career growth opportunities across QA, Regulatory Affairs, and Clinical Operations. • Dynamic and collaborative work culture focused on excellence and compliance.

The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product s safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products. Essential Functions Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable Provide aggregate reviews of safety information, including but not limited to clinical data, postmarketing, literature review and observational studies to maintain oversight of a product s safety profile (e.g: DSUR, RMP, PBRER, ad hoc regulatory reports etc) Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment. Ensure update of watch list, list of expectednsess, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable 24 hour medical support as required on assigned projects Maintain awareness of medical safety-regulatory industry developments Provide support and participate in signal detection efforts, e.g. strategy meetings etc. as applicable Qualifications Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education. Req Three (3 years) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training can qualify for clinical practice experience Req Two (2) years of pharma experience Pref Sound knowledge of Medicine In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Knowledge of Pharmacovigilance- ICSR and Aggregate reports In-depth knowledge of departmental standard operating procedures (SOPs) Skill in use of multiple safety databases Adequate Computer skills, especially Microsoft word, excel & PowerPoint Good communication skills- verbal and written Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representatives Ability to establish and maintain effective working relationships with coworkers, managers and clients A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation/Post Graduate Diploma in Finance/Bachelors degree with Finance specialization Years of Experience: 0 to 1 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 Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talent. You will be aligned with our Risk and Compliance vertical and help us perform compliance reviews, publish reports with actions and provide closure guidance as needed. We design & recommend effective controls to mitigate risks and help service delivery team prepare for upcoming client / external audits. You will be working as a part of the Risk & compliance team which is responsible for helping clients and organizations identify risks and create mitigation plans.Looking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for Ability to meet deadlinesAdaptable and flexibleProblem-solving skills 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 assignmentsThe decisions that you make would impact your own workYou will be an individual contributor as a part of a team, with a predetermined, focused scope of workPlease note that this role may require you to work in rotational shifts 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 Qualification Any Graduation,Post Graduate Diploma in Finance,Bachelors degree with Finance specialization

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

The Clinical Safety Reviewer (CSR) is responsible for evaluating and interpreting adverse events (AEs), serious adverse events (SAEs), and product safety data collected during clinical trials or post-marketing surveillance. The role ensures scientific and regulatory accuracy in case assessments, contributing to patient safety and regulatory compliance. Roles and Responsibilities; Review clinical safety data including ICSRs, SAEs, and narratives for accuracy and medical completeness. Assess seriousness, expectedness, and causality based on protocol, IB, and regulatory guidelines. Ensure the consistency of MedDRA coding and WHO Drug coding in line with global standards. Review and approve final case versions for submission to regulatory authorities. Collaborate with medical writers, PV associates, and biostatisticians on aggregate report contributions. Participate in signal detection and risk assessment meetings (as required). Ensure compliance with global pharmacovigilance regulations (e.g., ICH E2E, GVP). Eligibility / Qualifications: MBBS / BDS / BPharm / PharmD / MPharm / BHMS / BAMS with relevant PV training. Minimum1- 4 years experience in pharmacovigilance or clinical safety (mandatory for mid-level). Strong understanding of clinical trial protocols, GCP, MedDRA, and WHO-DD. Hands-on experience with PV databases like Argus , ARISg , or equivalent. Interested to apply can share you CV in Whatsapp/Call to 9342735755

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation/Post Graduate Diploma in Finance/Bachelors degree with Finance specialization Years of Experience: 0 to 1 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 Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentYou will be aligned with our Risk and Compliance vertical and help us perform compliance reviews, publish reports with actions and provide closure guidance as needed. We design & recommend effective controls to mitigate risks and help service delivery team prepare for upcoming client / external audits. You will be working as a part of the Risk & compliance team which is responsible for helping clients and organizations identify risks and create mitigation plans.Looking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for Ability to meet deadlinesAdaptable and flexibleProblem-solving skillsYou will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignmentsThe decisions that you make would impact your own workYou are expected to interact within your own team and direct supervisor Please note that this role may require you to work in rotational shiftsYou will be an individual contributor as a part of a team, with a predetermined, focused scope of work 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 Qualification Any Graduation,Post Graduate Diploma in Finance,Bachelors degree with Finance specialization

Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory New Associate Qualifications: BBA/BCom/Master of Business Administration Years of Experience: 0 to 1 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 Ability to meet deadlinesAbility to perform under pressureAbility to work well in a teamAdaptable and flexibleAgility for quick learning 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 Qualification BBA,BCom,Master of Business Administration

Benovymed Healthcare is a disruptive and an AI Health Tech Innovation Digital Health Global organization with its Founder & CEO working in Healthcare for over 26 years, an industry Global top Business Leader in AI Health Tech, Mobile Health Tech, MedTech digital health Tech, developing AI Tech Solutions for Nextgen after undergoing for last few years in deep R& D ( in advance future Medical Research, AI HealthTech, future HealthTech Business Management with a difference ) in Hospital Healthcare space for India & Globally & Applying AI Deep Learning, ML, NLP in major super Specialties for creating a High potential high growing company for creating a big difference in the Healthcare globally. Please visit us through our website at www.Benovymed.com. Job Type: Full Time / Part-Time to work Initially Remotely. Job Position : Sr.Scientist -Medical Oncology. Job Location: Delhi NCR. Initially Remotely anywhere in India. Job Description: - Currently, we are looking for strong experienced Medical Researcher Professionals with an entrepreneur mindset in Oncology Medical Research areas as below: - Passionate Post Doctoral Scientist with relevant experience working in Medical oncology Practice or in advanced Oncology Medical Research with a reputed Medical Research Hospital or in a startup /mid-size company to join our Organisation. Qualification : 1) MSc with PhD ( only Fulltime regular PhD program Holder with NET Qualified from reputed University ( NAAC grade A Government University needs to apply) in the area of Medical Oncology Research. Experience : 5 - 15 Years experience in Cancer Medical Research dealing with Cancer Patients and cancer patient data related, Post MSc, PhD in Medical Oncology by Research from Reputed Medical Research University needs to apply. CTC: - Best in the Healthcare industry. - Eligible Professional may apply to this job opportunity along with CV with passport size photo, your medical Practice / Research area, current & expected CTC, Notice period and Medical Practice / Research Projects details. This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

Benovymed Healthcare is a disruptive and an AI Health Tech Innovation Digital Health Global organization with its Founder & CEO working in Healthcare for over 26 years, an industry Global top Business Leader in AI Health Tech, Mobile Health Tech, MedTech digital health Tech, developing AI Tech Solutions for Nextgen after undergoing for last few years in deep R& D ( in advance future Medical Research, AI HealthTech, future HealthTech Business Management with a difference ) in Hospital Healthcare space for India & Globally & Applying AI Deep Learning, ML, NLP in major super Specialties for creating a High potential high growing company for creating a big difference in the Healthcare globally. Please visit us through our website at www.Benovymed.com. Job Type: Full Time / Part-Time to work Initially Remotely. Job Position : Sr.Scientist -Medical Oncology. Job Location: Delhi NCR. Initially Remotely anywhere in India. Job Description: - Currently, we are looking for strong experienced Medical Researcher Professionals with an entrepreneur mindset in Oncology Medical Research areas as below: - Passionate Post Doctoral Scientist with relevant experience working in Medical oncology Practice or in advanced Oncology Medical Research with a reputed Medical Research Hospital or in a startup /mid-size company to join our Organisation. Qualification : 1) MSc with PhD ( only Fulltime regular PhD program Holder with NET Qualified from reputed University ( NAAC grade A Government University needs to apply) in the area of Medical Oncology Research. Experience : 5 - 15 Years experience in Cancer Medical Research dealing with Cancer Patients and cancer patient data related, Post MSc, PhD in Medical Oncology by Research from Reputed Medical Research University needs to apply. CTC: - Best in the Healthcare industry. - Eligible Professional may apply to this job opportunity along with CV with passport size photo, your medical Practice / Research area, current & expected CTC, Notice period and Medical Practice / Research Projects details. This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.