
41255 - Assoc Medical Safety Dir
1 day 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
5 days 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
5 days 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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Principal Drug Safety Physician
3 days ago
Remote, India Parexel Full time**Job Purpose**: Principal Safety Physician is responsible for performing medical & safety monitoring tasks in the assigned projects and contribute to medical review, analysis and guidance in all required safety reports. Principal project teams, business development and pre-award activities. - Provide medical review, analysis and guidance during the case...
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Medical Advisor 736
1 day ago
Remote, India ProductLife Group Full timeProductLife 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 causality & seriousness...
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Medical Advisor 736
5 days 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 Representative
6 days ago
Remote, India Tegamen safety products Pvt. Ltd Full timeMedical Representative required for field work, need to visit hospitals for Orders and need to achieve targets. Need to provide leads and generate sales. Work Location: Remote
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Safety Writer
6 days ago
Remote, India Kateric Full time(India) **About Us** Kateric is a strategic partner for biopharmaceutical companies that consistently delivers superior quality regulatory documents through excellence, experience, and intelligent execution. Kateric’s resources are located across multiple time zones in the United States, as well as in India, the EU and Canada, and also have experience...
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Medical Advisor
6 days 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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Drug Safety Associate
2 days ago
Remote, India Fusion Market Research Full timeThe primary duty of a Drug Safety Associate involves the ongoing monitoring and evaluation of adverse effects and safety concerns associated with drugs and medical products following market approval. As a Drug Safety Associate, your responsibilities will include monitoring, assessing, and reporting adverse events related to pharmaceutical products. You will...
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Medical Writing Specialist
3 days ago
Remote, India beBeeMedicine Full time ₹ 1,04,000 - ₹ 1,30,878Medical Writer II Role SummaryWe are seeking an experienced Medical Writer II with a strong background in clinical study report (CSR) safety narratives writing. This role involves compiling, writing, and editing various medical writing deliverables to present scientific information clearly and accurately.Responsibilities:Compile, write, edit, and coordinate...