Associate Director, Patient Safety Scientist
Location: Bangalore, India
Job Type: Full-Time
Application Deadline: November 24, 2025
Job ID: R-239527
Category: Pharmacovigilance | Patient Safety | Drug Safety | Clinical Development
Job Overview
The Associate Director, Patient Safety Scientist plays a critical role in global pharmacovigilance activities and safety governance. This position works closely with Global Safety Physicians and Senior Patient Safety Scientists to review safety data, identify potential safety issues, and provide authoritative input into safety documents and regulatory submissions. The role also involves leading cross-functional discussions, coordinating safety strategies, and presenting safety analyses to internal and external stakeholders.
Key Responsibilities
Pharmacovigilance Strategy & Risk Management
Lead proactive safety surveillance and risk management planning for assigned products.
Develop safety components of Global Risk Management Plans in collaboration with Global Safety Physicians.
Evaluate safety signals and provide scientific insights for risk mitigation activities.
Cross-Functional Representation
Represent Patient Safety on global teams for marketed and developmental products.
Lead the Safety Strategy and Management Team (SSaMT) to drive consistent safety governance.
Present complex safety data at scientific and regulatory meetings.
Safety Data Review & Regulatory Documentation
Conduct comprehensive evaluation of safety data from clinical trials, pre-clinical studies, literature, and post-marketing sources.
Produce high-quality safety evaluation reports for internal stakeholders and health authorities.
Author and review Reference Safety Information (RSI) for assigned products.
Prepare or oversee key PV regulatory documents including PBRERs, PSURs, and DSURs.
Regulatory Submissions & Compliance
Provide strategic safety input to global submissions such as NDA/BLA and MAA.
Ensure compliance with global pharmacovigilance regulations, governance standards, and timelines.
Support safety due diligence for partnerships and external agreements.
Team Development & Collaboration
Train and guide junior safety scientists in PV tools, systems, and analytical methodologies.
Collaborate effectively with Clinical, Regulatory Affairs, and cross-functional teams to drive aligned safety strategy.
Required Qualifications & Experience
Education
Degree in Biosciences, Life Sciences, Pharmacy, Medicine, or an equivalent healthcare discipline.
Experience
9 to 11 years of core Patient Safety/Pharmacovigilance experience.
12 to 14 years of total industry experience in the pharmaceutical or clinical development domain.
Proven expertise in global safety regulations, risk management, and regulatory reporting.
Strong understanding of safety data interpretation, clinical development processes, and medico-legal aspects of PV.
Skills
Advanced scientific writing and analytical capabilities.
Strong interpersonal and cross-cultural communication skills.
Ability to collaborate effectively with global functions.
Confidence in presenting and defending safety findings to diverse audiences.
Impact on Business
Ensures accuracy and timeliness in regulatory safety reporting.
Strengthens product safety profiles through thorough data evaluation and surveillance.
Supports compliant processes, productivity, and operational excellence across Patient Safety functions.
Contributes to accurate product labeling and benefit-risk assessments.
Internal & External Stakeholders
Patient Safety teams at all levels
Clinical Development and Regulatory Affairs
Cross-functional global project teams
External partners, safety experts, and regulatory authorities
Leadership Competencies
Customer Focus: Ensures complete and high-quality safety solutions.
Strategic Thinking: Adapts and enhances existing PV approaches through broad scientific insight.
Decisive Action: Makes informed decisions under pressure with incomplete information.
Performance Ownership: Sets clear expectations and ensures delivery of high-quality outputs.
Collaboration: Integrates diverse perspectives in safety discussions and decisions.
Team Development: Mentors junior colleagues while maintaining personal growth.
Work Environment & Culture
This role supports a hybrid model, enabling meaningful in-person collaboration at least three days per week while allowing flexibility. The organization fosters innovation through diverse scientific teams working toward advancing life-changing medicines.
You will join a highly collaborative scientific community with a strong focus on oncology and patient outcomes. With an ambitious pipeline and commitment to breakthrough therapies, this is an opportunity to build a meaningful career while contributing to global health impact.
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Siliguri |Illinois :
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Auckland |New Zealand :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Japan | Saitama |Tokyo :
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