Manager Pharmacovigilance, Medical reviewer
Found in: Whatjobs IN C2 - 2 weeks ago
)Review and conduct medical assessment of Human and Veterinary Pharmacovigilance/ safety documents (including ICSRs and aggregate safety reports such as PADER/PSUR). )Perform medical review of serious and non-serious ICSRs with importance on the causality, seriousness, expectedness, MedDRA coding etc. )Review of literature articles for identification of ICSRs, safety and efficacy information for inclusion in aggregate reports, RMPs and signal reports. )Response to queries and requests related to safety of products and the pharmacovigilance system from internal and external stakeholders including health authorities. )Review of ICSRs received from sources such as Health authority, Partners, Spontaneous and Literature. )Facilitation of follow up for cases and product complaints. )Provide regular feedbacks to the case processors and ensure case quality. )Involvement in case quality improvement process and its implementation. )Provide trainings to the team for updates in the global pharmacovigilance guidelines and product trainings. )Preparation for Internal or External audits and inspections.
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Medical Reviewer
2 days ago
Mumbai, India Career Choice Solution Full timeMumbai Business/ Customer: - Perform medical review (including verifying the coding & labeling, reviewing seriousness, narratives, causality statement, medical aspect of followup request), validate followup request and perform medical assessment of the case as applicable. - Responsible for maintaining Medical cohesiveness of a case. - Maintaining the data...
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Senior Manager/ AGM Pharmacovigilance
Found in: Whatjobs IN C2 - 2 weeks ago
mumbai, India Unichem Laboratories Limited Full timeRole & responsibilitiesConduct and execute all pharmacovigilance related activities in Unichem lab.Train PV Team, corporate office, manufacturing plants and other vendors as applicable in timely manner.Ensure preparation and maintenance of pharmacovigilance documentation and SOPs and train relevant stake holders.Train the PV team to prepare periodic safety...
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Senior Manager/ AGM Pharmacovigilance
Found in: Whatjobs IN C2 - 2 weeks ago
Mumbai, India Unichem Laboratories Limited Full timeRole & responsibilities Conduct and execute all pharmacovigilance related activities in Unichem lab. Train PV Team, corporate office, manufacturing plants and other vendors as applicable in timely manner. Ensure preparation and maintenance of pharmacovigilance documentation and SOPs and train relevant stake holders. Train the PV team to prepare periodic...
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Senior Manager/ AGM Pharmacovigilance
Found in: Appcast Linkedin IN C2 - 2 weeks ago
Mumbai, India Unichem Laboratories Limited Full timeRole & responsibilities Conduct and execute all pharmacovigilance related activities in Unichem lab.Train PV Team, corporate office, manufacturing plants and other vendors as applicable in timely manner.Ensure preparation and maintenance of pharmacovigilance documentation and SOPs and train relevant stake holders.Train the PV team to prepare periodic safety...
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Senior Manager/ AGM Pharmacovigilance
Found in: Talent IN 2A C2 - 2 weeks ago
Mumbai, India Unichem Laboratories Limited Full timeRole & responsibilities Conduct and execute all pharmacovigilance related activities in Unichem lab.Train PV Team, corporate office, manufacturing plants and other vendors as applicable in timely manner.Ensure preparation and maintenance of pharmacovigilance documentation and SOPs and train relevant stake holders.Train the PV team to prepare periodic safety...
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Pharmacovigilance Associate
17 hours ago
Mumbai, Maharashtra, India Vertex Business Solutions Full time**Job description** **Responsibilities**: - Receive, review, and process adverse event reports and other safety information in accordance with established procedures and timelines. - Perform case assessment and documentation, including the identification of potential safety concerns and relevant medical information. - Ensure the quality and integrity of...
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Pharmacovigilance Physician Ii
7 days ago
Mumbai, India PrimeVigilance Full timeCompany Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...
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Executive Pharmacovigilance
Found in: Talent IN C2 - 2 weeks ago
Mumbai, India Piramal Group Full timeBusiness: Piramal Critical Care Department: Pharmacovigilance Location: Kurla, Mumbai Travel: Low Job Overview: The Executive Pharmacovigilance will be responsible end-to-end case management, including case receipt, facilitation of case follow-up, case download from regulatory authority websites, database entry, peer review and submission to...
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Pharmacovigilance Associate
5 days ago
Andheri West, Mumbai, Maharashtra, India Vertex Business Solutions Full time> A Pharmacovigilance Associate plays a crucial role in ensuring adherence to relevant regulations and standard operating procedures. Specializing in drug safety management, clinical trials, and medical supervision, their primary responsibilities include monitoring and reporting pharmacovigilance developments. They oversee processes to ensure the...
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Lead - Medical Reviewer
Found in: beBee S IN - 3 weeks ago
Mumbai, India Cognizant Technology Solutions Full timeAggregate report medical reviewer: Job description: - Attend Kick-off meeting organized by aggregate report writers to understand overall timeline requirements - Provide safety inputs at kick-off meeting by reviewing various documents (e.g. Previous aggregate report, labelling document, RMP, Health Authority Assessment Reports...
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Medical Affairs Manager
Found in: Whatjobs IN C2 - 22 hours ago
mumbai, India Hansa Medcell Full timeAs a Medical Affairs professional, you will contribute actively to devise and implement the medical affairs strategy, be a specialist in the therapy areas and allotted products/portfolios.Role: Medical Affairs ManagerExperience: 6 - 10 YearsLocation: Mumbai (Work from Office)Responsibilities:Handle all Medico Marketing activities & Medical Services, Medical...
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Medical Affairs Manager
Found in: Whatjobs IN C2 - 4 days ago
mumbai, India Hansa Medcell Full timeAs a Medical Affairs professional, you will contribute actively to devise and implement the medical affairs strategy, be a specialist in the therapy areas and allotted products/portfolios. Role: Medical Affairs Manager Experience: 6 - 10 Years Location: Mumbai (Work from Office) Responsibilities: Handle all Medico Marketing activities & Medical Services,...
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Medical Reviewer
1 day ago
Mumbai, India Tata Consultancy Services Full timeTCS is hiring for MBBS/MD professionals! **Role**: Medical Reviewer **Experience Range**: 1 to 7 Years **Qualification**: MBBS/MD only - Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). - Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment...
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Medical Affairs Manager
Found in: Appcast Linkedin IN C2 - 4 days ago
Mumbai, India Hansa Medcell Full timeAs a Medical Affairs professional, you will contribute actively to devise and implement the medical affairs strategy, be a specialist in the therapy areas and allotted products/portfolios.Role: Medical Affairs ManagerExperience: 6 - 10 YearsLocation: Mumbai (Work from Office)Responsibilities:Handle all Medico Marketing activities & Medical Services, Medical...
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Medical Affairs Manager
Found in: Talent IN 2A C2 - 4 days ago
Mumbai, India Hansa Medcell Full timeAs a Medical Affairs professional, you will contribute actively to devise and implement the medical affairs strategy, be a specialist in the therapy areas and allotted products/portfolios.Role: Medical Affairs ManagerExperience: 6 - 10 YearsLocation: Mumbai (Work from Office)Responsibilities:Handle all Medico Marketing activities & Medical Services, Medical...
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Medical Coder
1 week ago
Mumbai, Maharashtra, India Tata Consultancy Services Full timeResponsible for and/or contributes to the timelyand quality delivery of coded terms (for Adverse events, concomitantmedications, medical histories, medical procedures, etc.) and effective usageof medical and drug terminology, for clinical trials, pharmacovigilance,post-marketing safety surveillance, and other databases. 2. Assisting with the maintenance of...
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Pharmacovigilance Associate
1 week ago
Mumbai, Maharashtra, India Statistical Pharma Full time**Job description** - Responsible for review of investigational new drug safety reports (INDSR) and submission to FDA (as applicable) - Responsible for negotiation and implementation of pharmacovigilance agreements (PVA) with business partners - Supports PV Clinical Specialists in tasks and projects as needed - Responsible for identifying and developing...
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Medical Reviewer
5 days ago
Navi Mumbai, India Neural IT Full time**Industry Type**: IT / ITES **Designation**: Medical reviewer **Qualification**: Bpharm/mpharm **Experience**: 6 months to 4 years (REBUTTALS) **Skills Required**: - Sound knowledge of Pharmacology. - Proper understanding of various disease process, abnormal laboratory results, diagnosis and treatment. - Writing skills required. - Computer Skills. -...
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Safety Surveillance Physician
2 days ago
Mumbai, India Career Choice Solution Full timeBangalore, Mumbai, Nagpur, Pune Medical review of the ICSR's (clinical, spontaneous, Drug surveillance, literature and spontaneous) adhering to SOP designed by client. Keeping track of updates of the drug and cascade to drug safety, pharmacovigilance into clinical trials. Communication and discussion with the client to assure case coding with adherence to...
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Medical Advisor
1 day ago
Mumbai, Maharashtra, India Sun Pharmaceutical Industries Ltd Full time**Job Title**: **Medical Advisor **Job Category**: Head Office Based Medical Affairs **Department**: Medical Affairs **Qualification** MBBS with M.D. Pharmacology/Medicine or full time post-graduate qualification of at least 2-years’ duration in any discipline of medicine **Location**: Mumbai **Travel Required**: Yes **Reporting to**: GM Medical...