
41255 - Assoc Medical Safety Dir
3 days ago
As a global safety officer, provides PV expertise for assigned products, maintains PV expertise, and understanding of international safety regulations and guidelines. Provides and maintains PV and risk management expertise to internal and external customers. Maintains knowledge of product, their environment and recent literature. Communicates and represents PV data evaluation, interpretation and summary or conclusions as relevant. Responsible for signal detection and analysis. as well as review, preparation, and/or contribution to responses to questions from health authorities, ethics committees, Internal Review Boards (IRBs), external partners. Manages product safety alerts, as needed. Responsible for Identifying and implementing proactive safety analysis strategies to further define the safety profile of the product. Provides proactive risk assessment. Responsible for documenting, coordinating, reviewing and validating periodic reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report, Health Hazard Evaluation etc., leads the preparation of clinical overview to support labelling changes and oversees the safety part of the Company Core Safety Information (CCSI/CCDS) creation/ update. Prepares for and particpates in the SMC and SMT meetings and also provides inputs during labellling working group meetings. Participates and provides inputs for audit related activities (internal and external partners). Prepare the List of safety concerns/ list of safety topics for a product based on the existing RSI and properties of the product.
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Case Medical Safety Expert
1 day ago
Remote, India IQVIA Full timeMajor duties and responsibilities: - oversees the Medical Review (MR) of ICSRs as per predefined activity and job-role in PV safety database, with special focus on case medical accuracy and documentation, - maintains overall accountability for the timeliness and quality of medical case management activities outsourced to service providers, - leads or...
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Assoc Dir, Biostatistics
1 day ago
Remote, India Syneos Health Clinical Full time**Description** **Associate Director, Biostatistics** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to...
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Drug Safety Physician
3 days ago
Remote, India cGxPServe Full time**Responsibilities**: - Monitor patient safety during clinical trials by reviewing adverse events, SAEs, and providing medical assessments. - Ensure timely and accurate reporting of SAEs and safety signals to regulatory authorities. - Provide medical expertise to clinical study teams, investigators, and safety personnel for safety - related queries and...
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Drug Safety Associate Ii
1 day ago
Remote, India Parexel Full time**Job ID** R0000031576 **Category** Medical Sciences **ABOUT THIS ROLE**: **Job Purpose**: - The Drug Safety Associate II, will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures...
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Medical Advisor 736
1 day ago
Remote, India ProductLife Group Full timeMedical Advisor 565 ProductLife Group is looking for a Medical Advisor to join our dynamic team on the following missions: **Responsibilities**: Contribute to signal management activities and aggregate report Perform medical evaluation of safety documents Medical review and inputs in case processing Medical inputs in the literature assessment Perform...
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Medical Advisor
1 day ago
Remote, India ProductLife Group Full timeWe are looking for a Team lead/ Manager/ senior medical advisor/reviewer proficient in all aspects of clinical and post-marketing drug safety. **Responsibilities**: Clinical Phase: - Lead as a medical monitor/Medical expert - Medical Monitoring experience is a must and the ability to effectively communicate with the clients, attend investigator meetings as...
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Medical Advisor – VAF
1 day ago
Remote, India productlife group Full time ₹ 12,00,000 - ₹ 36,00,000 per yearWe are looking for a Team lead/ Manager/ senior medical advisor/reviewer proficient in all aspects of clinical and post-marketing drug safety.Responsibilities:Clinical Phase:Lead as a medical monitor/Medical expertMedical Monitoring experience is a must and the ability to effectively communicate with the clients, attend investigator meetings as required and...
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Drug Safety Specialist
1 week ago
Remote, India Parexel Full time ₹ 9,00,000 - ₹ 12,00,000 per yearPrimary Location: India, RemoteJob ID R Category Medical SciencesABOUT THIS ROLEKey Accountabilities:The below responsibilities vary as per applicable as per the job role.GeneralMaintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client's guidelines, and SOPs, and Global drug safety...
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Safety & Pv Submission Spec Ii
1 day ago
Remote, India Syneos - Clinical and Corporate - Prod Full time**Description** **Senior Safety & Pharmacovigilance Submissions Specialist** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model...
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Medical Data Reviewer
1 day ago
Remote, India ICON Full timeICON 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. **What you will be doing**: Serve as a Clinical Data reviewer and identify any errors in data by...