Job Title:
Pharmacovigilance Science Expert
Job Location:
Hyderabad, India
Company:
Sanofi
Job Type:
Full-time, Global Role
Role Overview:
As a Pharmacovigilance (PV) Science Expert at Sanofi, you will join a dynamic and globally distributed team focused on ensuring patient safety and effective benefit-risk management across the product lifecycle. You’ll partner closely with Global Safety Leads and Managers to support safety surveillance, signal detection, and regulatory documentation for both marketed and investigational products.
Key Responsibilities:
Safety Surveillance & Signal Management:
Conduct core signal detection activities by synthesizing data from multiple sources including safety databases, literature, and external references.
Coordinate and draft Health Hazard Evaluations (HHEs) and Safety Evaluation Reports (SERs).
Manage SMART tool entries for signal tracking and assist Global Safety Leads with tool-related activities.
Review periodic signal detection outputs (NINR, UDR, SD reports).
Regulatory Support & Documentation:
Contribute to responses for Health Authority queries in collaboration with the Safety Team.
Participate as a core member of the Safety Management Committee (SMC), including preparation of outputs and slide decks.
Support safety content development for regulatory submissions, EU Risk Management Plans (RMPs), and other documentation.
Provide support for OTC SWITCH SERs.
Cross-functional Collaboration:
Coordinate risk and benefit-risk assessments for marketed products.
Collaborate across departments: PV Quality, Medical Affairs, Regulatory, Labeling, and external vendors.
Mentor new PV Safety Scientists and support audit/inspection readiness.
Lead specific safety science tasks, including stakeholder communication and deliverable timelines.
Required Skills & Competencies:
Technical & Scientific:
Proficiency in evaluating and synthesizing scientific safety data.
Strong understanding of PV practices, including US/EU regulatory frameworks.
Expertise in signal and risk management throughout the product lifecycle.
Skilled in scientific writing, logical analysis, and medical interpretation.
Soft Skills:
Strong communication and negotiation abilities.
Effective stakeholder management and cross-functional collaboration.
Strategic thinking and leadership in global environments.
High attention to detail, professional integrity, and adaptability.
Experience:
5–8 years of experience in drug safety, pharmacovigilance, or related functions.
Familiarity with regulatory guidelines and medical coding systems.
Experience in managing global safety processes and tools.
Education:
Master’s degree in a healthcare-related field (MPharm, MHSc, MBBS, BDS, or equivalent).
Languages:
Fluent English (verbal and written)
Why Join Sanofi?
Be part of a global healthcare leader committed to making miracles happen by pursuing progress and embracing innovation. At Sanofi, diversity, equity, and inclusion are the foundation of our culture, and your unique background will help shape the future of health.
Gujarat :
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