Job Title:
Pharmacovigilance Agreements Expert
Location:
Hyderabad, India
Company:
Sanofi
Department:
CHC – Consumer Safety (Global Science Center of Excellence)
Role Overview:
The Pharmacovigilance Agreements (PVA) Expert is responsible for managing PV Agreements for Consumer Healthcare (CHC) products, including development, execution, maintenance, and life cycle management. This role involves strategic planning, operational excellence, cross-functional collaboration, and support for inspection readiness related to PV Agreements.
Main Responsibilities:
Manage PVA lifecycle activities: planning, execution, maintenance, amendments, and termination.
Provide strategic input for PV Licensing activities and processes.
Liaise with internal and external stakeholders: Regulatory, Legal, Business Development, Contractual Partners, etc.
Lead/co-lead PV-related projects and drive operational excellence.
Promote awareness of PV Licensing deliverables across CHC teams.
Ensure alignment with CHC Business Development objectives.
Support the creation and maintenance of the global PVA repository and SharePoint (access, organization).
Actively support and facilitate team meetings, sharing best practices and process improvements.
Technical Tasks:
Support the setup of new PVAs, amendments, and termination letters.
Support PSMF (Pharmacovigilance System Master File) and PSR (Periodic Safety Reports) partner tracker maintenance.
Maintain and update monthly partner contact listings for SMEs.
Assist PVA Manager in revising Quality Documents (QDs).
Oversee the global rollout of PVAs and manage SharePoint tools.
Experience Required:
Minimum 5 years in pharmacovigilance, drug safety, or ICH-GxP-related operations.
At least 2+ years of experience in PVA process management is mandatory.
Experience in Consumer Healthcare (CHC) or pharmaceutical industry preferred.
Demonstrated ability in KPI tracking, operational improvement, and strategic project leadership.
Soft Skills:
Strong stakeholder engagement and cross-functional team leadership.
Strategic thinking with the ability to implement vision operationally.
Excellent organizational and project management abilities.
Strong written and verbal communication.
Problem-solving mindset, attention to detail, and proactive execution.
Technical Skills:
In-depth knowledge of international regulations, ICH-GxP guidelines, and PV best practices.
Strong understanding of end-to-end vendor and contract management.
Ability to evaluate business impacts and drive sourcing-related initiatives.
Experience setting up or building functional capabilities from the ground up is highly valued.
Education:
Higher university degree (L.L.B, JD, MBA) mandatory.
Background in medical or life sciences education is preferred.
Languages:
Fluent in English (verbal and written)
Why Join Sanofi?
At Sanofi, you’ll be part of a team that values diversity, inclusion, and the power of innovation. You’ll work in a collaborative, globally connected environment where you can pursue progress and discover extraordinary.
Sanofi is an equal opportunity employer committed to providing opportunities to all regardless of background, gender, orientation, disability, or identity.
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