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Manager - Pharmacovigilance

2.00 to 8.00 Years   Mumbai City   01 Feb, 2021
Piramal Glass
Job LocationMumbai City
EducationNot Mentioned
SalaryRs 1.5 - 6 Lakh/Yr
IndustryManufacturing
Functional AreaDoctor
EmploymentTypeFull-time

Job Description

*Job Responsibilities:

  1. Manage Case Processing and medical writing teams. Manage adverse event reporting/ submission within required timelines and requirements, as applicable to regulatory authorities.
  2. Signal management for company medicinal products.
  3. Management of Pharmacovigilance system master file (PSMF) and detailed description of Pharmacovigilance system (DDPS)
  4. Management of essential medicinal product safety profile documents including aggregate safety reports (PSUR, PADER, etc.) for Human and Veterinary products.
  5. Support in responding to queries and requests related to safety profile of medicinal products and Pharmacovigilance system.
  6. Prepare for internal or external/ regulatory audits and inspections.
  7. Impart Pharmacovigilance training to company personnel.
  8. Manage risk management plans (RMP).
Actively participate in activities associated with Pharmacovigilance Quality Assurance., *M.B.B.S. Doctrate Degree or equivalent from a reputed medical institution

Keyskills :
risk management plansproduct safetyrisk managementmedical writingcase processingregulatory auditsriskwritingtrainingmanagementveterinaryregulatorymilestonesmedical

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