41255 - Assoc Medical Safety Dir
1 week 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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Drug Safety Physician
1 week 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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Principal Drug Safety Physician
5 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
7 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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Medical Advisor – VAF
2 weeks 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 Associate
3 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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Drug Safety Specialist
1 day ago
Remote, India Parexel Full time ₹ 40,00,000 - ₹ 80,00,000 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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Assoc Dir, Fsp 360
5 days ago
Remote, India Syneos - Clinical and Corporate - Prod Full time**Description** JOB SUMMARY Provides leadership, direction, and management to FSP 360 functional teams. Provides training, consultation and oversees quality related to operating activities of assigned staff to ensure project deliverables are met. May liaise with other departments or business units to optimize resources as well as to establish harmonized...
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Safety Regulatory Intelligence Associate
2 weeks ago
Remote, India IQVIA Full timeJob Overview - Maintain a repository of, and communicate on, international, regional and national legislations, recommendations and guidelines related to vigilances for all ranges of products such as medicinal products, medical devices, cosmetics, nutraceuticals. - Appropriately identify and address potential regulatory issue that may have an impact on the...
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Medical Writer Ii
2 weeks ago
Remote, India Parexel Full timeParexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and...
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Senior Medical Writer
2 weeks ago
Remote, India Syneos Health Commercial Solutions Full time ₹ 15,00,000 - ₹ 25,00,000 per yearDescriptionCan you sift through data to find connections that give meaning?You relish making sense out of detail and finding the information that will answer challenging strategic questions. If this sounds like you, a role as a Senior Medical Writer within Medical Communications at Syneos Health is the perfect place to grow your career. In this role you...