PHARMAFull-time
Safety Operations Advisor 1
BANGALORE (IN)ONSITEPOSTED: 9/28/2026
PHARMAFull-time
HIRING ORGANIZATIONNOVO NORDISKPharmaceuticals / Healthcare
ROLE OVERVIEW
Provide medical expertise across global pharmacovigilance operations by evaluating adverse events, performing medical reviews and causality assessments, ensuring regulatory reporting compliance, and driving consistent safety practices across clinical and post-marketing programs.
ROLE DEFINITION & RESPONSIBILITIES
- •Conduct medical interpretation and evaluation of adverse events from clinical trials and post-marketing sources
- •Ensure compliance with global requirements for collection, evaluation, and expedited reporting of serious adverse events
- •Perform medical reviews and causality assessments and evaluate potential product relationships
- •Participate in clinical project teams from protocol design through trial conduct to address safety requirements
- •Lead cross-functional groups and chair safety meetings across projects and geographies
- •Establish improved safety methods and share best practices, including accurate MedDRA coding
- •Train investigators, clinical safety associates, and affiliate partners on safety-data handling and adverse-event management
Reporting Hierarchy: Part of Safety Operations within Global Patient Safety, Global Business Services; collaborates with Global Development, Regulatory Affairs, Data Management, clinical project teams, affiliates, investigators, and safety stakeholders worldwide
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- MBBS or equivalent medical degree
- Documented experience in drug safety evaluation, pharmacovigilance, or pharmacoepidemiology
- Strong knowledge of international regulatory requirements including ICH-GCP, EMA, and FDA guidelines
- Ability to perform independent medical causality assessments and safety decisions
- Strong analytical and systematic approach with attention to detail
- Excellent written and spoken English and cross-cultural communication skills
PREFERRED QUALIFICATIONS
- •Postgraduate medical qualification
- •Experience across multiple therapeutic areas
- •Experience leading cross-functional safety groups
- •Training and mentoring experience
- •Experience with global clinical development and post-marketing safety operations
REQUIRED VERIFIED SKILLS
Pharmacovigilance
drug safety
medical review
adverse-event evaluation
causality assessment
MedDRA
ICH-GCP
EMA guidelines
FDA guidelines
clinical safety
post-marketing surveillance
expedited reporting
safety data management
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Continuous professional development; international exposure; opportunities to work with advanced safety systems and methodologies; career and life-stage benefits; global collaboration opportunities.
The supplied posting does not disclose salary, bonus, or equity. Compensation should be confirmed directly with Novo Nordisk; no figures are inferred.
ORGANIZATION CONTEXT & CULTURE
Novo Nordisk is a global healthcare company focused on developing treatments for serious chronic diseases, with global operations spanning research, development, manufacturing, and patient safety.
TEAM SIZE: 60,000+ employees
INDUSTRY: Pharmaceuticals / Healthcare
Culture: Novo Nordisk emphasizes patient safety, scientific curiosity, collaboration, continuous improvement, diversity, shared purpose, and international teamwork.
EXPECTED CAREER ROADMAP
Potential progression into senior Safety Operations, Global Patient Safety, Pharmacovigilance Medical, Safety Science, or safety leadership roles, with opportunities for international exposure and broader cross-functional responsibilities.
APPLICATION ADVISORY
Highlight medical qualification and documented pharmacovigilance/drug-safety experience; demonstrate independent causality assessment and serious-adverse-event review; emphasize ICH-GCP, EMA/FDA regulatory knowledge, MedDRA, clinical-trial safety, post-marketing surveillance, and cross-functional leadership; include examples of training or mentoring safety stakeholders.
RECOMMENDED TRAINING
1/5
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