Safety Surveillance Adviser

About the role

The Safety Surveillance Adviser will lead the safety monitoring of Novo Nordisk products throughout their lifecycle, from clinical development to post‑marketing. The role works closely with Global Patient Safety, regulatory, and clinical teams to ensure a robust benefit‑risk profile and compliance with health‑authority requirements.

Key responsibilities

• Conduct continuous safety surveillance and signal detection from global data sources.
• Prepare and review aggregate safety reports such as DSURs, PSURs, PBRERs, SUSARs and Risk Management Plans.
• Maintain and update safety sections of the Company Core Data Sheet and support label change requests.
• Provide safety input for clinical trial documents, investigator brochures, and informed consent materials.
• Present safety analyses and recommendations to cross‑functional safety committees.
• Support regulatory submissions related to safety updates and ensure documentation meets internal and external standards.

Required profile

• Relevant experience in pharmacovigilance, signal management, and individual case safety report (ICSR) processing.
• Background in drug safety surveillance, preferably with clinical safety or lifecycle safety management exposure.
• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field.

Required skills

• ICH guidelines
• ICSR case processing
• Labeling assessment
• MedDRA coding
• WHO DD coding
• mRS and EQ‑5D‑5L scoring
• Triage of ICSRs

What we offer

• Competitive salary package (₹18 – ₹35 LPA) and comprehensive benefits.