Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Safety Surveillance Adviser

Novo Nordisk
Novo Nordisk
3+ years
preferred by company
Bangalore, India
1 May 13, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes

Job Title: Safety Surveillance Adviser

Location: Bangalore, Karnataka, India
Job Type: Full-Time
Experience Required: Relevant industry experience required (Freshers are not eligible)
Industry: Pharmacovigilance / Drug Safety / Regulatory Affairs / Pharmaceuticals / Life Sciences
Department: Global Patient Safety / Safety Surveillance

About the Role
We are seeking a highly analytical and medically oriented Safety Surveillance Adviser to support global pharmacovigilance, benefit-risk evaluation, aggregate safety reporting, and product safety surveillance across the drug development lifecycle. This role is ideal for professionals with expertise in signal detection, aggregate safety reporting, risk management, clinical safety monitoring, and global pharmacovigilance strategy.

The ideal candidate will be responsible for monitoring and evaluating product safety profiles across pre-approval and post-marketing phases, ensuring regulatory compliance, patient safety, and effective global safety communication.

This is an excellent opportunity for pharmacovigilance and medical safety professionals seeking strategic exposure to global patient safety operations.

Key Responsibilities

Safety Surveillance & Benefit-Risk Management

  • Conduct ongoing safety surveillance of pharmaceutical products across clinical development and marketed lifecycle stages.
  • Evaluate global safety data from multiple sources to support continuous benefit-risk assessment and product safety monitoring.
  • Support establishment and maintenance of product safety profiles for developmental and marketed products.
  • Identify, assess, and communicate emerging safety concerns and risk signals proactively.

Signal Management & Safety Evaluation

  • Perform signal detection, signal validation, safety data analysis, and pharmacovigilance risk assessment activities.
  • Review safety trends, adverse event patterns, aggregate data, and benefit-risk indicators.
  • Support clinical and post-marketing safety decision-making using evidence-based safety evaluation.
  • Collaborate with global safety stakeholders to address evolving pharmacovigilance concerns.

Aggregate Reporting & Regulatory Safety Documentation

  • Author and contribute to aggregate safety reports including DSURs (Development Safety Update Reports), PSURs/PBRERs, SUSAR reports, and Risk Management Plans (RMPs).
  • Support regulatory safety responses for health authorities and internal global stakeholders.
  • Ensure high-quality, timely preparation of pharmacovigilance documentation aligned with regulatory expectations.
  • Maintain compliance with global aggregate reporting timelines and safety governance requirements.

Product Labelling & Safety Communication

  • Support development and maintenance of product safety labelling including Company Core Data Sheets (CCDS) and marketed product labelling updates.
  • Provide safety input for label change requests (LCRs) and global product safety communications.
  • Ensure labelling content accurately reflects evolving product safety profiles and regulatory expectations.

Clinical Safety Support & Development Programs

  • Provide safety input to clinical trial protocols, Product Development Plans (PDPs), Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), integrated safety summaries, and clinical publications.
  • Support medical safety oversight for ongoing clinical studies.
  • Assist with safety-related responses to Ethics Committees, regulatory authorities, and internal clinical stakeholders.

Cross-Functional Safety Governance

  • Participate in or lead cross-functional safety governance committees and benefit-risk review forums.
  • Present ongoing safety surveillance findings, risk evaluations, and recommendations to internal stakeholders.
  • Collaborate closely with clinical development, regulatory affairs, medical safety, and pharmacovigilance teams globally.

Stakeholder Training & Safety Communication

  • Support investigator training and internal safety communication initiatives.
  • Provide safety expertise to project teams and cross-functional stakeholders.
  • Ensure proactive communication of significant safety observations and risk management recommendations.

Required Qualifications

  • MBBS with MD / Master’s in Medicine preferred or equivalent advanced medical qualification.
  • Relevant experience in pharmacovigilance, signal management, aggregate reporting, medical safety, or clinical drug safety.
  • Strong expertise in signal detection, aggregate safety reporting, ICSR review, risk management, and pharmacovigilance compliance.
  • Experience authoring or supporting DSURs, PSURs/PBRERs, RMPs, CCDS updates, and safety regulatory documentation.
  • Good understanding of global pharmacovigilance regulations, benefit-risk evaluation frameworks, and drug safety governance.
  • Strong proficiency in Microsoft Office tools and safety documentation workflows.
  • Excellent analytical thinking, medical judgment, stakeholder communication, and adaptability in dynamic environments.

Preferred Skills