We're Hiring: Medical Monitor – Pharmacovigilance ?
Location:
Mumbai, India (Office-based, Full time) ?
Experience:
5–7 years in Pharmacovigilance ? Qualification: MD (Pharmacology) or Infectious Disease (ID) Specialist ? Supporting: India & USA We are 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
• Perform medical review and causality assessment of individual case safety reports (ICSRs)
• Support signal detection, evaluation and validation activities
• Review aggregate safety data and contribute to periodic safety reports (PSURs/PBRERs, DSURs)
• Provide medical input for risk management and benefit-risk assessments
• Collaborate with cross-functional teams including Regulatory, Clinical and Medical Affairs
• Ensure compliance with Indian (CDSCO/PvPI) and US FDA safety regulations
• Strong expertise in causality assessment and signal management
• Good understanding of global PV regulations and guidelines (ICH, FDA, CDSCO)
• Excellent analytical, medical writing and communication skills Share your CV at
[email protected]
📌 Medical Monitor/Medical Writer (Mumbai)
🏢 Wockhardt
📍 Mumbai