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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Safety Physician
2 weeks ago
Remote, India Syneos Health Clinical Full time**Description** **Safety Physician** 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 help our customers...
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Drug Safety Associate Ii
2 days 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 565
2 weeks 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
2 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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Safety Regulatory Intelligence Associate
1 week 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 Writing Officer
2 weeks ago
Remote, India ProductLife Group Full timeProductLife Group is looking for a Medical Writing Officer to join our dynamic team to contribute to the activities performed in the Hub: **Responsibilities**:Signal Management and Regulatory Intelligence**: Perform Signal Management Activities for clients Preparation of Signal Schedule Maintenance of Signal trackers Sharing of recommendation with...