Safety Operations Advisor

Novo Nordisk

. Conduct medical interpretation and evaluation of adverse events from clinical trials and post-marketing surveillance .

Posted 9/21/2026full-timeBangalore • IndiaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in drug safety evaluation and pharmacovigilance, with a strong understanding of international regulatory requirements and the ability to conduct independent medical assessments. Proficient in training and mentoring teams while ensuring compliance with safety protocols and best practices.

Highest-signal resume keywords

Medical Degree (MBBS or Equivalent)Drug Safety EvaluationPharmacovigilanceInternational Regulatory RequirementsCausality Assessment

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Medical ReviewAdverse Event EvaluationMedDRA CodingClinical Trial Protocol DesignRegulatory Compliance

Soft Skills

Excellent Communication SkillsAnalytical ApproachAttention to DetailAbility to Manage Multiple PrioritiesTraining and Mentoring

Certifications & Qualifications

Postgraduate Medical Qualification Preferred

Industry Keywords

ICH-GCPEMA GuidelinesFDA GuidelinesClinical SafetyTherapeutic Areas

About the role

Key responsibilities & impact

Conduct medical interpretation and evaluation of adverse events from clinical trials and post-marketing surveillance
Ensure compliance with global regulatory requirements for collection, evaluation, and expedited reporting of serious adverse events to health authorities
Perform medical reviews and causality assessments of serious adverse events
Determine potential relationships between serious adverse events and Novo Nordisk products
Participate in clinical project teams from protocol design through trial conduct
Lead cross-functional groups and chair safety meetings
Establish improved methods and share best practices to enhance safety deliverables and ensure accurate MedDRA coding
Train investigators, clinical safety associates, and affiliate partners on safety data handling and adverse event management
Collaborate with Global Development, Regulatory Affairs, Data Management, and affiliates worldwide

Requirements

What you’ll need

Medical degree (MBBS or equivalent)
Postgraduate medical qualification preferred
Documented experience in drug safety evaluation, pharmacovigilance, or pharmacoepidemiology
Strong knowledge of international regulatory requirements, including ICH-GCP, EMA, and FDA guidelines
Comprehensive understanding of clinical manifestations, disease management, and medical treatment across various therapeutic areas
Proven ability to perform independent medical causality assessments and make critical decisions regarding drug safety issues
Strong analytical and systematic approach with excellent attention to detail
Ability to work under tight regulatory timelines
Fluency in English, written and spoken
Excellent communication skills for collaborating across cultural and linguistic differences
Ability to manage multiple priorities
Ability to train and mentor others

Benefits

Comp & perks

Continuous professional development
International exposure
Opportunity to work with cutting-edge safety systems and methodologies
Inclusive recruitment process and equality of opportunity