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Country Safety Head India

0-2 years
Not Disclosed
10 Sept. 12, 2025
Job Description
Job Type: Full Time Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Country Safety Head (CSH)

Location: [Insert Location]
Department: Patient Safety & Pharmacovigilance (PSPV) – PV Regions
Company: Sanofi


About the Team

The Patient Safety & Pharmacovigilance (PSPV) team aspires to be a cutting-edge safety group, enabling Sanofi to optimize the benefit–risk balance of therapies and best serve patients and consumers.

The PV Regions group is a dynamic, international, and culturally diverse team dedicated to ensuring the safety of Sanofi products across countries and regions.


Position Overview

The Country Safety Head (CSH) (or Multi-Country Safety Head, M-CSH) is responsible for ensuring that all local pharmacovigilance (PV) activities are conducted in compliance with global, regional, and local PV regulations and PSPV Quality Documents (QDs). This role guarantees the safe and appropriate use of Sanofi products in the assigned country or countries.


Key Responsibilities

Leadership & Representation

  • Act as the face of the Safety organization in the country.

  • Serve as the local Responsible Person for Pharmacovigilance (RPP), where applicable per legislation (delegation possible).

  • Operate as Local Safety Officer (LSO) for assigned local products under oversight of the Regional Medical Safety Head (delegation possible).

Pharmacovigilance Operations

  • Ensure all PV activities are compliant, effective, and inspection-ready.

  • Act as primary PV contact for local health authorities.

  • Oversee outsourced PV activities and compliance of local partnerships.

  • Ensure local PV teams are trained and equipped to manage activities.

Stakeholder Management

  • Build and maintain strong collaborations with PSPV stakeholders, other CSHs, and in-country partners (Medical, Regulatory, Quality, Commercial, Legal, Country Leads).

  • Engage with Export Market partners and promote compliance with PVA and PV requirements.

  • Manage the India PV team overseeing Export Market Partners (as applicable).

Resource & Budget Management

  • Accountable for local PV resources and budgets in collaboration with local and global functions.


Required Experience

  • Strong experience in pharmacovigilance systems and safety-related product management (clinical development and marketed products).

  • Experience with regulatory agency interactions.

  • Knowledge of international/national PV regulations and industry standards (including medical products, vaccines, and medical devices when relevant).

  • Familiarity with high-quality safety documents (e.g., RMP, PBRER).


Education

  • Advanced degree in healthcare discipline (MD, PharmD, PhD, MSc, MPH, or equivalent).

  • Other medical/scientific backgrounds may be considered with sufficient PV experience.

  • MBA or business degree is a plus.


Languages

  • Full professional proficiency in English (verbal and written).

  • Must meet local language requirements to serve as RPP, where applicable.


Technical & Functional Competencies

Pharmacovigilance Expertise

  • Strong knowledge of PV systems, regulations, and compliance.

  • Ability to manage safety data from multiple sources.

  • Skilled in safety signal detection, assessment, and risk identification.

  • Expertise in defining and implementing risk management activities.

  • Ability to assess and optimize benefit–risk balance throughout product lifecycle.

Medical & Clinical Knowledge

  • Ability to interpret clinical and safety data.

  • Awareness of regulatory, therapeutic, and clinical environments impacting product safety.

Strategic Insight & Engagement

  • Generate and incorporate safety insights into development, commercialization, and regulatory strategies.


Leadership & Behavioral Competencies

  • Judgment: Effective decision-making in ambiguous or incomplete situations.

  • Team Leadership: Build and inspire high-performance, accountable teams.

  • Interpersonal Skills: Demonstrate sensitivity, respect, and adaptability in diverse environments.

  • Personal Leadership: Lead with courage, integrity, and accountability.

  • Drive: Exhibit passion, commitment, and focus on delivering results.

  • Learning Agility: Adapt quickly, apply learning in new situations, and drive continuous improvement.


Soft Skills

  • Strong leadership and people management.

  • Excellent networking, collaboration, and influencing skills.

  • Strategic, solution-oriented thinker with patient- and customer-centric focus.

  • Effective communicator with attention to detail and ability to see the big picture.


Additional Notes

  • The CSH must comply with all local PV legislation requirements for RPP responsibilities.

  • Oversight responsibilities for Export Markets (managed by India PV team) require strong negotiation and persuasion skills.


Sanofi Commitment

At Sanofi, we provide equal opportunities regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status, or any other characteristics protected by law.

We are committed to diversity, equity, and inclusion. Discover more at sanofi.com.


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