Instagram
youtube
Facebook

Pharmacovigilance Agreements Expert

5+ years
Not Disclosed
10 April 22, 2025
Job Description
Job Type: Full Time Education: L.L.B/JD/MBA 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

 

Pharmacovigilance Agreements Expert

Location: Hyderabad, India
Position Type: Permanent
Posted On: April 21, 2025
Closing On: April 30, 2025


About the Company:

At Sanofi, we are driven by a shared purpose to pursue progress and discover extraordinary. We bring together people from diverse backgrounds, united by the ambition to create miracles through innovation, collaboration, and bold ideas. We embrace change and offer opportunities for growth within a global environment committed to diversity, equity, and inclusion.


Main Responsibilities:

  • Manage Pharmacovigilance (PV) Agreements for CHC products, overseeing planning, execution, maintenance, lifecycle management, and termination of PVAs.

  • Support strategy setting and ensure inspection readiness concerning PV Agreements.

  • Develop Pharmacovigilance Agreements (PVAs) and facilitate PVA processes across the CHC organization in collaboration with internal and external stakeholders.

  • Provide guidance and lead or co-lead projects related to PV Licensing processes and business partnerships.

  • Promote awareness and understanding of PV Licensing deliverables across key internal and external interfaces (Regulatory, Business Development, Legal, Contractual Partners).

  • Take informal leadership roles during meetings to facilitate agreements and drive deliverables.

  • Support development and alignment of PV Licensing strategies with CHC Business Development goals.

  • Collaborate with functional lines and subject matter experts to implement planning, execution, and governance strategies.

  • Drive collaborative partnerships with stakeholders impacting CHC products.


Technical Tasks:

  • Support setup of PVA lifecycle activities, including amendments, termination letters, and new PVAs.

  • Assist with PSMF PVA activities.

  • Maintain and support PSR partner trackers.

  • Provide monthly partner contact listings to SMEs.

  • Support revision and simplification of PVA processes.

  • Manage PVA roll-out and maintain the global PVA repository/SharePoint.


About You:

Experience:

  • Minimum 5 years’ experience in consumer healthcare, pharmaceuticals, or related industries, with at least 2+ years specifically in PVA process management.

  • Strong operational excellence in pharmacovigilance or drug safety.

  • Experience in driving KPI tracking, continuous improvement, and cross-functional initiatives.

  • Deep understanding of ICH-GxP regulations, guidelines, and good practices.

  • Familiarity with KPI calculations is preferred.

  • Prior experience leading global teams and managing large multi-country budgets is essential.

Soft Skills:

  • Strong stakeholder management, negotiation, and communication skills.

  • High attention to detail, proactive mindset, and effective problem-solving abilities.

  • Excellent organizational and project management capabilities.

  • Ability to work effectively in cross-functional, multicultural environments.

  • Strategic thinking and leadership in team settings.

Technical Skills:

  • Ability to implement strategic efficiency and develop both strategic and operational visions.

  • Expertise in evaluating the transversal business impact of decisions.

  • Proficient knowledge of end-to-end Vendor and Contract Management.

  • Strong experience in pharmacovigilance standards and practices.

Education:

  • Higher University degree (L.L.B, JD, MBA) is mandatory.

  • Basic education in the Medical Science stream is required.

Languages:

  • Fluent in English (verbal and written).


Commitment to Diversity:

At Sanofi, we are committed to providing equal opportunities for all, irrespective of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.