Medical Director – Patient Safety Physician (Pharmacovigilance Leadership Role)
Location: India (Bengaluru / Chennai)
Job Type: Full-Time
Company: AstraZeneca
Experience Required: 10+ years
Job Overview
The Medical Director – Patient Safety Physician is a senior leadership role responsible for driving pharmacovigilance strategy and ensuring the highest standards of patient safety across AstraZeneca’s global portfolio. This position plays a critical role in evaluating drug safety profiles, supporting benefit-risk assessments, and ensuring compliance with global regulatory requirements. The role demands strong medical expertise, strategic thinking, and cross-functional collaboration to enhance patient outcomes and support the development of innovative therapies.
Key Responsibilities
Provide medical leadership and oversight for pharmacovigilance and patient safety activities across clinical development and post-marketing programs. Lead the medical review and assessment of adverse events, ensuring accurate evaluation of causality, seriousness, and benefit-risk balance. Drive safety signal detection, evaluation, and risk management strategies to support patient safety and regulatory compliance. Collaborate with cross-functional teams including clinical development, regulatory affairs, medical affairs, and epidemiology to ensure integrated safety strategies. Contribute to the development and review of safety documents including Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), and aggregate safety reports. Provide expert medical input into regulatory submissions and interactions with global health authorities. Support inspection readiness and participate in audits, ensuring adherence to global pharmacovigilance regulations and internal standards. Mentor and guide junior safety physicians and pharmacovigilance professionals to build high-performing teams. Maintain in-depth knowledge of therapeutic areas, product safety profiles, and evolving regulatory landscapes.
Education and Qualifications
Medical degree (MD or equivalent) is required. Advanced qualifications or specialization in clinical research, pharmacovigilance, or related therapeutic areas are preferred.
Experience Requirements
Minimum 10+ years of experience in pharmacovigilance, clinical safety, or drug development within the pharmaceutical or biotechnology industry. Significant experience in safety signal management, risk assessment, and regulatory submissions is essential. Prior experience in leadership or strategic roles within global safety organizations is highly desirable.
Key Skills and Competencies
Strong expertise in pharmacovigilance regulations, global safety standards, and risk management frameworks. Proven ability to lead cross-functional teams and influence stakeholders across global organizations. Excellent analytical and clinical judgment skills for evaluating complex safety data. Strong communication and presentation skills with the ability to convey medical insights to diverse audiences. High level of organizational and project management capability to manage multiple priorities. Strategic mindset with a focus on innovation, continuous improvement, and patient-centric outcomes.
Work Environment
This role may involve a combination of office-based and field-based responsibilities, including participation in global meetings, stakeholder discussions, and strategic planning sessions. Flexibility and strong organizational skills are essential to manage dynamic priorities.
Why Join AstraZeneca
AstraZeneca offers an opportunity to work at the forefront of scientific innovation, contributing to the development of life-changing medicines. With a strong presence in India and a global footprint, the organization provides a collaborative environment, access to cutting-edge technologies, and a commitment to advancing healthcare outcomes worldwide.
Uttar Pradesh :
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Siliguri |Illinois :
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