Jr Assoc Pharmocovigilance

Novo Nordisk; Bengaluru; In loco; INR 350.000 - 600.000; Tempo pieno

Descrizione del lavoro

Novo Nordisk India Pvt Ltd (Affiliate) in Bengaluru is seeking a Jr Assoc Pharmacovigilance to support safety data handling and timely reporting to local authorities. You will work under supervision to build expertise in safety case processing and regulatory compliance.

The role emphasizes accurate documentation, collaboration with Global Safety and cross-functional teams, and growth in pharmacovigilance within an international OPS context.

Competenze

• Bachelor’s degree in pharmacy; master’s preferred.
• Training in pharmacovigilance basics or safety databases preferred.
• 1–2 years in pharmacovigilance or drug safety is helpful.
• Understanding of ICH, PvPI guidelines and GVP is beneficial.
• Strong documentation and communication skills.

Mansioni

• Receive, document and report adverse events and PQCs within timelines.
• Monitor safety mailbox and handle safety information via multiple channels.
• Execute ICSR lifecycle tasks in Veeva Safety and Veeva Quality.
• Perform data checks, source data verification and reconciliations.
• Support safety reporting to Health Authorities and audits readiness.
• Maintain safety databases and submission trackers, ensuring retrievability.

Conoscenze

Pharmacovigilance basics

Adverse event reporting

ICSR processing

Documentation skills

Veeva Safety

Veeva Quality

MS Office

English fluency

Prioritisation & timelines

Formazione

Bachelor's degree in pharmacy

Master's degree (M. Pharm or PharmD) preferred

Strumenti

Veeva Safety

Veeva Quality

Descrizione del lavoro

Department: Pharmacovigilance

Location: Novo Nordisk India Pvt Ltd (Affiliate)

Your impact begins here

As Jr Assoc Pharmacovigilance, you will help make sure safety information reaches the right people at the right time. You will process adverse events and product quality complaints, support timely reporting to local Health Authorities and keep safety records accurate and inspection-ready. Working in International Operations, you will turn every report into reliable data that supports people using Novo treatments and strengthens pharmacovigilance operations.

What You’ll Bring

• A bachelor’s degree in pharmacy, A Master’s degree (M. Pharm or PharmD) is preferred.
• Training in pharmacovigilance basics or safety databases is preferred. If you have experience, 1–2 years in pharmacovigilance or drug safety is what we are looking for.
• A basic understanding of pharmacovigilance processes, adverse event reporting and ICSR processing, and of regulatory guidelines such as ICH, the New Drugs and Clinical Trials Rules 2019 (NDCT), Pharmacovigilance Programme of India (PvPI) guidelines and applicable Good Pharmacovigilance Practices (GVP).
• Good written and verbal communication, strong attention to detail and solid documentation skills.
• Familiarity with Veeva Safety or Veeva Quality.
• The ability to prioritise tasks, meet timelines, work collaboratively and escal...
• Proficiency in Microsoft Office applications.
• Fluency in English.

What You’ll Do

You will be part of the local safety process from first report to closure, working under appropriate supervision while building your own expertise.

• Receive, document and report adverse events (AEs), product quality complaints (PQCs) and AEs associated with PQCs to Global Safety within required timelines, including follow-up until closure.
• Monitor the safety mailbox and handle safety information and customer complaints received by phone, through digital applications and via internal safety portals.
• Carry out assigned activities across the ICSR lifecycle in Veeva Safety and Veeva Quality, from intake, assessment and case narrative preparation to quality review, submission, follow-up and closure.
• Perform quality checks, source data verification and reconciliations, so cases are accurate, complete and consistent.
• Support the preparation, submission and tracking of clinical trial safety reports (including SUSARs and SAEs) and post-marketing ICSR to Health Authorities.
• Maintain safety databases, submission trackers and pharmacovigilance records, and keep documentation complete and retrievable for audits and inspections.
• Support monitoring of local PV requirements, flag new or amended requirements to Global Safety, and help track compliance activities, escalating potential delays or issues early.

Who You’ll Work With

In International Operations, colleagues work across markets to serve people around the world and help improve health at scale. In this role, you will be part of the local pharmacovigilance team.

Your closest partner is Global Safety, which receives your reports and relies on your timeliness and accuracy. You will also collaborate with Clinical, Regulatory, Medical and other relevant colleagues to complete PV activities on time, and you will be in direct contact with customers when handling complaints and safety information.

What You Can Expect Here

You will be trusted to own your work and supported to do it well. You will build practical skills in safety databases, case processing and regulatory requirements, learn on the job from experienced colleagues and through relevant learning offerings, and complete the training needed to grow in pharmacovigilance. Clear expectations on quality and timelines mean you will know what good looks like and be recognised for delivering it.

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