Medical Writer Job at Wockhardt Ltd., Mumbai
Wockhardt Ltd. is hiring a Medical Monitor – Pharmacovigilance in Mumbai, India, on a full-time, office-based basis. The role requires 5–7 years of Pharmacovigilance experience and an MD (Pharmacology) or Infectious Disease (ID) Specialist qualification.
Job Details
Company: Wockhardt Ltd.
Position: Medical Monitor/Medical Writer
Location: Mumbai, India
Job Type: Office-based, Full-time
Experience: 5–7 years in Pharmacovigilance
Supporting: India & USA
Job Description
Wockhardt Ltd. is looking for an experienced Medical Monitor to join our Pharmacovigilance team and play a key role in safety evaluation and signal detection across our India and US portfolios.
Key Responsibilities
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Perform medical review and causality assessment of individual case safety reports (ICSRs)
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Support signal detection, evaluation and validation activities
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Review aggregate safety data and contribute to periodic safety reports (PSURs/PBRERs, DSURs)
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Provide medical input for risk management and benefit-risk assessments
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Collaborate with cross-functional teams including Regulatory, Clinical and Medical Affairs
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Ensure compliance with Indian (CDSCO/PvPI) and US FDA safety regulations
Eligibility Criteria
Qualification: MD (Pharmacology) or Infectious Disease (ID) Specialist
Experience: 5–7 years in Pharmacovigilance
Required Skills
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Strong expertise in causality assessment and signal management
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Good understanding of global PV regulations and guidelines (ICH, FDA, CDSCO)
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Excellent analytical, medical writing and communication skills