15 Oct
|
Novo Nordisk
|
Bengaluru
15 Oct
Novo Nordisk
Bengaluru
Department name - Regulatory Affairs and Pharmacovigilance
Organization - Novo Nordisk India Pvt Ltd (Affiliate)
Location - Bangalore
Your impact begins here
As Associate Pharmacovigilance Manager, you will act as the local Pharmacovigilance Responsible Person for our affiliate, overseeing drug safety across clinical development and post-marketing settings. You will make sure every safety report is accurate, complete and submitted on time, keeping health authorities informed and partners aligned. Your work keeps safety observation moving reliably, so decisions about our treatments rest on quality data and people living with serious chronic diseases can use them with confidence.
What You’ll Bring
You are an experienced pharmacovigilance skilled who takes ownership and keeps safety reporting on track when timelines are tight. You will bring:
• 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 es
📌 Associate Pharmacovigilance Manager (Bengaluru)
🏢 Novo Nordisk
📍 Bengaluru