Senior Associate Pharmacovigilance

Senior Associate Pharmacovigilance Clinical, Medical & Regulatory Jakarta, Indonesia

Are you passionate about safeguarding patient safety? Do you want to play a pivotal role in ensuring regulatory compliance and the safety of medicines? If so, we are looking for a Senior Associate Pharmacovigilance to join our Clinical, Medical, and Regulatory team at Novo Nordisk. Read on and apply today!

Your new role The Senior Associate Pharmacovigilance position will give you the opportunity to ensure Novo Nordisk Indonesia Pharmacovigilance System is established, maintained and in compliance with global and local requirements. Other responsibilities are included but not limited to:

Plan and deliver affiliate pharmacovigilance activities, including adverse event handling, internal safety requirements, oversight, quality control, and support for market research.

Ensure compliance with global and local PV regulations, including timely reporting of safety cases to health authorities and adherence to Safety Data Exchange Agreements (SDEAs).

Maintain and manage individual case safety reports (ICSRs), monitor safety mailboxes, and keep trackers up to date.

Provide pharmacovigilance training, collaborate with cross-functional teams, contribute to signal detection and risk management, and develop local PV Standard Operating Procedure (SOPs).

Support audit and inspection readiness by managing non-conformities and implementing corrective and preventive actions (CAPAs), and represent PV in affiliate initiatives.

Your new department You will be joining the Clinical, Medical & Regulatory department at Novo Nordisk. This dynamic team is dedicated to ensuring regulatory compliance for new products and product amendments, safeguarding patient safety, and maintaining our license to operate. The Regulatory Affairs function focuses on gaining regulatory approval for clinical trials, new drugs, devices, and digital health solutions, while also shaping future regulatory frameworks through collaboration with health authorities and policymakers. The Safety Pharmacovigilance function ensures the safety of our medicines, collecting and analysing safety data, and addressing any product safety issues.

Your skills & qualifications

Bachelor’s degree in Life Sciences, Pharmacy, Medicine or related field with a minimum of 3 years of experience in a reputable pharma company.

Familiarity with safety surveillance, clinical trial safety, and post‑marketing reporting with high level of accuracy, precision and responsibilities in work assigned.

Knowledge of international and local regulatory guidelines and requirements and risk management strategies is advantageous.

Innovation and creative with good project management skills along with good command of both written and spoken English.

Proficient in basic MS Office (Word, PowerPoint, and Excel) and familiarity with use of databases.

Working at Novo Nordisk Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination and a constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results. Deadline 24 December 2025. Applications will be screened on an ongoing basis.

Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.

#J-18808-Ljbffr