Pharmacovigilance Job at Takeda, Bengaluru
Ready to lead global drug safety strategies with one of the world’s leading biopharmaceutical companies? Takeda is hiring a Medical Director, MPMD, PSPV in Bengaluru, Karnataka. This Pharmacovigilance Job in Bengaluru offers experienced medical professionals the opportunity to drive global pharmacovigilance strategies, benefit-risk assessments, safety surveillance, and regulatory interactions across Takeda’s product portfolio. The position at Takeda Careers is ideal for physicians with extensive experience in Drug Safety and Pharmacovigilance who are passionate about advancing patient safety and regulatory excellence. Candidates with strong scientific expertise and leadership capabilities are encouraged to apply.
About the Company:
Takeda is a global, values-based, research and development-driven biopharmaceutical company committed to improving health and transforming lives. With a strong presence across multiple therapeutic areas, Takeda focuses on delivering innovative medicines and healthcare solutions to patients worldwide.
The company combines cutting-edge science, advanced technology, and patient-centered innovation to address some of the world’s most challenging healthcare needs. Takeda operates globally while maintaining a strong commitment to ethics, quality, regulatory compliance, and scientific excellence.
Job Details:
- Position: Medical Director, MPMD, PSPV
- Location: Bengaluru, Karnataka, India
- Job ID: R0182649
- Category: Research & Development
- Subcategory: Research & Development
- Business Unit: Research & Development
- Employment Type: Full-Time
- Worker Type: Employee
- Worker Sub-Type: Regular
- Time Type: Full Time
- Work Arrangement: Remote (as per Takeda’s Hybrid and Remote Work Policy)
- Travel Requirement: Local and International Travel as Required
- Flexibility Requirement: Support for US Eastern Time Zone Activities When Needed
Key Responsibilities:
Global Safety Leadership
- Serve as the Global Safety Lead (GSL) for assigned pharmaceutical, biological, and drug-device combination products.
- Define and execute global safety strategies throughout the product lifecycle.
- Act as the company-wide subject matter expert in patient safety.
- Deliver major safety outputs supporting development and lifecycle management.
Safety Governance and Team Leadership
- Lead PSPV Global Safety Team (GST).
- Lead Safety Management Team (SMT).
- Ensure alignment on safety priorities across functions.
- Drive timely safety-related decision-making.
- Establish accountability across cross-functional teams.
Risk-Benefit Management
- Conduct comprehensive benefit-risk assessments.
- Manage product safety profiles throughout development and commercialization.
- Develop proactive risk minimization strategies.
- Identify and mitigate emerging safety risks.
Safety Data Analysis and Signal Management
- Analyze safety data from non-clinical studies, clinical studies, post-marketing data, real-world evidence, and scientific literature.
- Conduct signal detection and monitoring.
- Perform signal evaluation and interpretation.
- Manage safety signals in accordance with global regulatory requirements.
Regulatory and Compliance Activities
- Develop strategies for responding to safety-related regulatory inquiries.
- Prepare scientifically robust responses for regulatory authorities.
- Support interactions with the FDA, EMA, PMDA, and other Global Regulatory Agencies.
- Maintain inspection-ready safety documentation.
- Ensure compliance with global pharmacovigilance regulations.
Medical Writing and Documentation
- Provide medical review and authorship support for Clinical Protocols, Protocol Amendments, Informed Consent Forms (ICFs), Investigator Brochures (IBs), Investigational Medicinal Product Dossiers (IMPDs), Clinical Study Reports (CSRs), Health Hazard Evaluations (HHEs), Signal Evaluation Reports (SERs), IND Applications, NDA Applications, BLA Applications, CTA Submissions.
Clinical Development Support
- Integrate safety considerations into clinical development programs.
- Contribute to study design and protocol development.
- Provide input on statistical analysis plans.
- Support safety endpoint selection and evaluation.
- Ensure appropriate safety characterization during development.
Labeling and Risk Management
- Author and maintain Risk Management Plans (RMPs).
- Ensure accurate safety information in Company Core Data Sheet, Reference Safety Information, Investigator Brochure, Product Labeling Documents.
Stakeholder Collaboration
- Collaborate with Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal Teams.
- Ensure aligned and consistent safety communication across functions.
Training and Mentorship
- Train Pharmacovigilance Physicians.
- Mentor Safety Scientists.
- Provide scientific guidance and expertise.
- Support capability building within the safety organization.
- Promote continuous learning and scientific excellence.
Innovation and Technology
- Leverage quantitative methodologies in safety surveillance.
- Support the use of Artificial Intelligence in pharmacovigilance activities.
- Ensure scientific validity and regulatory acceptability of emerging technologies.
Educational Requirements for the Pharmacovigilance Job:
- MD, DO, or internationally recognized equivalent medical qualification.
Preferred
- Board Certification.
- Medical Licensure.
- Relevant clinical experience following postgraduate training.
- Strong grounding in General Medicine, Epidemiology, Biostatistics.
Skills Required:
- Advanced Pharmacovigilance expertise.
- Drug Safety and Risk Management knowledge.
- Signal Detection and Signal Management experience.
- Aggregate Safety Reporting expertise.
- Safety Labeling and Benefit-Risk Assessment capabilities.
- Clinical Development and Clinical Research understanding.
- Regulatory Affairs knowledge.
- Knowledge of FDA, EMA, PMDA, and ICH guidelines.
- Scientific data interpretation and analysis skills.
- Medical writing and regulatory documentation expertise.
- Leadership and team management capabilities.
- Strategic decision-making skills.
- Stakeholder engagement and influencing abilities.
- Cross-functional collaboration skills.
- Excellent verbal and written communication skills.
- Problem-solving and critical thinking abilities.
- AI and quantitative methodology awareness in safety surveillance.
Experience Required:
- Minimum 5 years of experience in Drug Safety/Pharmacovigilance.
- Minimum 3 years of post-marketing safety experience.
- Demonstrated expertise in Aggregate Reporting, Safety Surveillance, Signal Management, Safety Labeling, Benefit-Risk Assessment, Risk Management.
- Experience responding to safety-related regulatory inquiries.
- Experience working with global regulatory agencies.
Benefits of the Pharmacovigilance Job:
- Opportunity to work with a globally recognized biopharmaceutical company.
- Leadership role in global patient safety and pharmacovigilance.
- Exposure to international regulatory and safety programs.
- Opportunity to influence global drug development strategies.
- Collaboration with multidisciplinary global teams.
- Involvement in cutting-edge safety science and innovation.
- Exposure to AI-driven pharmacovigilance initiatives.
- Flexible remote working arrangement.
- International travel and networking opportunities.
- Strong career growth prospects in global medical affairs and drug safety leadership.
