Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy.
Post : Associate Pharmacovigilance Manager
Job Description
Responsible for leading and overseeing local pharmacovigilance activities, including adverse event case processing, safety reporting to Health Authorities, customer complaint handling, regulatory compliance, data quality, and stakeholder collaboration across clinical development and post-marketing activities.
Your focus will be on :
• Acting as the local PV Responsible Person, monitoring local PV requirements, sharing new or amended requirements with Global Safety and making sure they are implemented on time.
• Leading and performing end-to-end ICSR processing in the database (Veeva Safety and Veeva Quality) from intake, assessment, case narration, quality review, submission, follow-up and closure – and validating data against source documents and call notes.
• Managing health authority submissions of clinical trial safety reports, including Suspected Unexpected Serious Adverse Reactions (SUSARs) and Serious Adverse Events (SAEs), post marketing cases (ICSR’s) and coordinating and reviewing Periodic Safety Update Reports (PSURs).
• Responsible for managing safety observation and customer complaints received through email, phone, digital applications, and internal portals, ensuring accurate and timely reporting in Veeva Safety and Veeva Quality and completing all required follow-up activities within established timelines.
• Oversee end-to-end pharmacovigilance activities, including safety training, adverse event management, mailbox reconciliation, follow-ups, and timely reporting of safety observation in compliance with applicable SOPs and regulatory requirements.
• Manage partners and vendors supporting Customer Engagement Programmes and Organised Data Collection Systems, ensuring up-to-date safety and pharmacovigilance agreements, effective PV training and onboarding, and compliance with agreed quality standards and timelines.
• Leading affiliate PV audits and audits of Patient Support Programme and Market Research Programme partners, owning findings and corrective and preventive actions (CAPAs), maintaining inspection readiness and supporting the affiliate during potential and actual product recalls.
• Driving PV process development and continuous improvement, and speaking up early when issues could delay case processing or submission.
Candidate Profile
• A Bachelor’s or Master’s degree in Pharmacy, or a PharmD.
• 7–10 years of relevant experience, including at least 7 years in pharmacovigilance, drug safety or a related field.
• Strong hands-on experience in post-marketing case processing and end-to-end individual case safety report (ICSR) management.
• Proficiency in ICH E2A, E2B(R3) and E2D guidelines, the New Drugs and Clinical Trials Rules, 2019 (NDCT), Pharmacovigilance Programme of India (PvPI) guidelines and applicable Good Pharmacovigilance Practices (GVP).
• Strong knowledge of pharmacovigilance quality systems, regulatory reporting requirements and SOP implementation.
• Experience working in Veeva Safety and Veeva Quality, and basic proficiency of MedDRA.
• Experience working directly with external partners, clients and cross-functional stakeholders, supported by strong written and verbal communication skills.
• A strong understanding of scientific principles and drug safety concepts, and proficiency in Microsoft Office.
• The ability to work independently with sound judgement, organise and prioritise multiple deadlines, pay close attention to detail and escalate issues early.
• A flexible, collaborative approach and the ability to adapt as requirements and processes change.
• Experience in managing Customer Engagement Programmes and Organised Data Collection Systems.
Additional Information
Experience : 7–10 years
Qualification : Bachelor’s or Master’s degree in Pharmacy, or a PharmD
Location : Bangalore, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs and Pharmacovigilance
End Date : 15th November 2026
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