Medical Director, Patient Safety Physician
By Admin · Pharmacovigilance & Drug Safety
ROLE OVERVIEW
AstraZeneca's Medical Director, Patient Safety Physician role places a medically qualified safety leader at the centre of benefit-risk decision-making for high-impact therapies spanning late-stage development through post-marketing. Based in Bengaluru, the position owns the clinical safety strategy for assigned programmes, defining identified and potential risks, setting safety go/no-go criteria, and shaping risk-minimisation approaches that ultimately influence labelling and regulatory outcomes. Because AstraZeneca's pipeline stretches across oncology, cardiovascular, respiratory and rare disease, this is a rare opportunity to work on genuinely transformative medicines while collaborating with regulators, QPPVs and external partners. For physicians seeking to move beyond bedside practice into strategic pharmacovigilance leadership, it offers exceptional visibility, cross-cultural exposure and durable long-term career capital.
ROLE DEFINITION & RESPONSIBILITIES
- •Own the clinical safety strategy for assigned products across late-stage development and post-marketing, defining identified and potential risks and proposing mitigation measures.
- •Lead risk management planning by reviewing and endorsing core Patient Risk Management Plans, safety specifications and pharmacovigilance plans.
- •Provide strategic clinical safety input into development planning; review and approve investigator brochures, protocols, informed consents and study reports.
- •Direct signal detection and evaluation activities, including medical review of individual case safety reports and collaboration with external data providers.
- •Supply medical input to labelling updates, Developmental Core Safety Information and responses to regulatory authority requests.
- •Review periodic safety reports such as PBRERs, PSURs and DSURs, and lead Patient Safety contributions to NDA, BLA and MAA submissions.
- •Represent Patient Safety on clinical and project teams; facilitate Safety Management and Safety Review Teams and urgent safety issue taskforces.
- •Mentor junior safety physicians and scientists, maintain inspection readiness and drive pharmacovigilance process improvement initiatives.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Medical degree (MBBS, MD or equivalent) with valid clinical registration.
- At least 2 years of post-registration clinical experience preferred.
- Up to 11-13 years of Patient Safety or pharmacovigilance experience with clear evidence of delivery.
- Approximately 16 years of total professional experience in the pharmaceutical or biopharmaceutical industry.
- Detailed knowledge of global regulatory requirements governing expedited and periodic safety reporting, signal generation and risk management.
- Demonstrated leadership of Safety Management Teams and cross-functional governance forums.
- Willingness to work on-site in Bengaluru at least three days per week and travel internationally as required.
PREFERRED QUALIFICATIONS
- •Direct interaction with global regulators such as FDA, EMA or MHRA on safety and labelling topics
- •Experience in oncology or other high-priority therapeutic areas
- •Safety Agreements and licensing partner collaboration
- •Due diligence assessments and product liability support
- •Documented mentorship of junior safety scientists and physicians
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
AstraZeneca is a global, science-led biopharmaceutical company focused on the discovery, development, and commercialisation of prescription medicines. The company operates in various therapeutic areas, including Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. AstraZeneca is committed to pushing the boundaries of science to deliver life-changing medicines and improve patient outcomes worldwide.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
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