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Job Description & How to Apply Below
We are seeking an experienced Pharmacovigilance professional with strong expertise across drug development, registration, and post-approval phases for New Chemical Entities (NCEs) . The role will be responsible for end-to-end safety activities, regulatory compliance, signal management, and benefit–risk assessment across global programs.
Key Responsibilities
Lead and manage PV safety activities for assigned New Chemical Entities (NCEs)
Ensure timely completion of safety deliverables in compliance with global regulations and internal SOPs
Define safety data acquisition strategy, methodology, and analytical approach
Review and provide input on study protocols, safety management plans, and safety reporting requirements
Review adverse events (AEs) and serious adverse events (SAEs) from clinical studies
Review safety data (tables, figures, listings), Clinical Study Reports (CSRs), and Investigator Brochures (IBs)
Support development of safety-related data collection forms for clinical trials
Oversee signal management activities, including literature surveillance, documentation, and tracking
Plan and review periodic aggregate safety reports including DSURs, PSURs, PBRERs, ADCOs , and line listings
Manage responses to regulatory authority queries (USFDA, Health Canada, PRAC RFIs) related to PV
Review and support labelling justification documents from a PV perspective
Contribute to risk management strategy and development of Risk Management Plans (RMPs)
Support new drug applications and other regulatory filings
Collaborate with cross-functional teams:
Clinical, Regulatory Affairs, Medical Writing, Labelling, QPPV, and CROs
Act as interface between global project leads, CROs, and internal teams
Participate in Safety Governance activities
Support internal audits and regulatory inspections
Qualifications & Skills
MD/MBBS or Doctorate in Life Sciences / Pharmacy / Medicine
7–8 years of relevant experience in Pharmacovigilance / Drug Safety
Strong exposure to clinical and post-marketing PV activities
Hands-on experience with aggregate reports, signal management, and regulatory interactions
Good understanding of global PV regulations (ICH, EMA, USFDA)
Excellent communication, stakeholder management, and documentation skills
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