Associate Pharmacovigilance Manager

Novo Nordisk India Pvt Ltd; Bengaluru; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Novo Nordisk India Pvt Ltd in Bangalore seeks an Associate Pharmacovigilance Manager to lead local pharmacovigilance activities, ensuring accurate safety reporting and compliance across clinical development and post‑marketing. You will act as the local PV Responsible Person, coordinating with Global Safety and cross‑functional teams.

The role requires 7+ years in pharmacovigilance, strong ICH/GVP knowledge, and hands‑on experience with Veeva systems and MedDRA.

Qualifications

• 7–10 years of relevant experience, including at least 7 years in pharmacovigilance, drug safety or a related field.
• Hands-on experience in post‑marketing case processing and end‑to‑end ICSR management.
• Proficiency in ICH E2A, E2B(R3) and E2D guidelines, NDCT 2019 and PvPI guidelines.
• Strong knowledge of PV quality systems, regulatory reporting requirements and SOP implementation.
• Experience with Veeva Safety/Quality and MedDRA proficiency.
• Experience with external partners and cross‑functional stakeholders; strong written/verbal communication.
• Solid understanding of scientific principles and drug safety concepts; proficient in Microsoft Office.
• Ability to work independently, manage multiple deadlines, and escalate issues early.
• Flexible, collaborative approach and adaptability to changing processes.
• Experience managing Customer Engagement Programmes and Organised Data Collection Systems.

Responsibilities

• Lead local PV activities including adverse event processing and safety reporting to health authorities.
• Act as the local PV Responsible Person, monitoring local requirements and implementing changes.
• End‑to‑end ICSR processing in Veeva Safety/Quality from intake to submission and closure.
• Manage safety submissions (SUSARs/SAEs), PSUR reviews, and follow‑ups within timelines.
• Oversee safety observations and customer complaints via multiple channels with timely reporting.
• Coordinate PV training, data quality, mailbox reconciliation and regulatory compliance.
• Manage partners and vendors for Customer Engagement Programmes and data systems.

Skills

Pharmacovigilance

ICSR processing

Veeva

MedDRA

Regulatory reporting

Communication skills

Microsoft Office

Cross-functional collaboration

Education

Bachelor’s or Master’s degree in Pharmacy or PharmD

Tools

Veeva Safety

Veeva Quality

MedDRA

Job description

Associate Pharmacovigilance Manager

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

• 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 elevate 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.

What you’ll do

• 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.
• 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.

Who you’ll work with

You will join the Pharmacovigilance function in our affiliate within International Operations, where colleagues work across markets to serve people around the world and help improve health at scale. You will report to [insert hiring manager name and title]. Your closest internal partner will be Global Safety, and you will work day to day with Clinical, Medical and Regulatory teams, as well as Training, Finance, Legal, Product Supply and Logistics, Sales and Marketing. Externally, you will be the go‑to contact for health authorities, liaison contacts, PV service providers, contract research organisations (CROs), consultants, business partners and PSP/MRP partners. These relationships keep safety reporting accurate and on time. You will bring clarity on requirements and timelines, so work moves forward at speed.

What you can expect here

You will be trusted with real ownership: the role carries accountability for local PV compliance, audit outcomes and the quality of safety data reported from the affiliate. Your expertise will be valued, and you will be encouraged to make your voice heard as you shape how PV processes are developed, implemented and improved. Working across clinical development and post‑marketing activities, and with many functions and partners, you will broaden your perspective and build new skills on the job – supported by colleagues who care about quality and each other.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Experience Level Mid Level