Pharmacovigilance Manager

Role & Responsibilities
• Perform medical review of company, literature, and regulatory ICSRs
• Select and assess adverse events for seriousness and expectedness
• Conduct MedDRA coding review of adverse events
• Review causality assessments and perform label assessment
• Classify product role (suspect, concomitant, interacting)
• Review medical history, concomitant conditions, and laboratory data
• Evaluate case narratives for medical accuracy and completeness
• Perform medical review and quality review of aggregate safety reports (PSURs, PADERs)
• Conduct medical review of Risk Management Plans (RMPs)
• Review Signal Management Reports and support signal evaluation

Qualification
• MBBS or MD (Pharmacology preferred)

Experience
• Relevant experience in pharmacovigilance medical review or drug safety preferred

Skills
• Strong knowledge of pharmacovigilance regulations and safety reporting standards
• MedDRA coding proficiency
• High attention to clinical detail and document quality
• Strong written and verbal communication skills
• Ability to work with global safety documentation and regulatory timelines

About the Company
The hiring organization operates in regulated pharmacovigilance and drug safety domains, supporting global pharmaceutical safety surveillance, aggregate reporting, and risk management activities aligned with international regulatory standards.