CV-Library
Senior Manager Pharmacovigilence and Medical Information
12 MONTH FIXED TERM CONTRACT ROLE – FULL TIME – 1 DAY PER WEEK IN CENTRAL LONDON
About the role
My client is a private‑equity backed specialty pharmaceutical company entering a new phase of growth, and as such, are looking for a Senior Manager, Pharmacovigilance and Medical Information to build and lead best‑in‑class PV and MI capabilities across their portfolio. You will work closely with the UK/EU QPPV, external partners, and internal stakeholders to ensure robust compliance with UK/EU PV legislation and relevant Codes of Practice, while shaping scalable processes that can support future launches, in‑licensing deals, and acquisitions.
As the PV and MI subject matter expert, you will be the primary point of contact for vendors and business partners and a trusted adviser to internal teams. This role is ideal for someone who enjoys making informed decisions, takes full ownership, and thrives in a fast‑paced, change‑driven environment where PE backing means the business is actively investing, evolving, and doing deals.
You will be highly organised, comfortable managing multiple workstreams, and proactive in driving tasks forward with minimal supervision. For the right person, this is an opportunity to put their stamp on how a modern PV and MI function operates within an ambitious, growth‑oriented specialty pharma platform.
Core responsibilities
* Serve as the main point of contact for all PV and MI activities across the organisation.
* Coordinate day‑to‑day interactions with third‑party PV and MI vendors and support oversight of their compliance with contracts and applicable regulations.
* Partner closely with the appointed UK/EU QPPV to ensure effective oversight of all required PV processes.
* Create, negotiate, and maintain PV and MI vendor agreements, including associated budgeting responsibilities.
* Review agreements prepared by other functions where PV obligations or liabilities may be impacted.
* Review and approve the UK/EU PV System Master File, ensuring it remains accurate and inspection‑ready.
* Track and assess PV and MI vendor KPIs and metrics, driving performance improvements where needed.
* Review and approve MI standard response documents and provide support to the MI vendor for complex or second‑line enquiries.
* Draft, implement, and maintain safety data exchange agreements (SDEAs) as required.
* Collaborate with business partners to ensure that SDEAs are implemented and adhered to in practice.
* Author, review, and refine PV and MI SOPs and related quality documents, with a focus on continuous improvement and operational clarity.
* Proactively challenge and enhance existing procedures to support efficiency, scalability, and inspection readiness.
* Ensure PV and MI activities are conducted in line with data protection requirements, including GDPR.
* Lead PV aspects of regulatory inspections and internal/external audits.
* Maintain oversight of PV audits of business partners and PV/MI vendors, including follow‑up on corrective and preventive actions.
* Conduct PV and MI due diligence to support potential in‑licensing opportunities, partnerships, and acquisitions, working closely with BD and commercial colleagues.pestakeholder+1
* Lead PV and MI integration activities following mergers and acquisitions to ensure a smooth and compliant transition
Ethical and compliance responsibilities
* Role‑model the organisation’s values and contribute to a high‑integrity, patient‑centric culture.
* Support a forward‑looking approach to environmental, social, and governance (ESG) responsibilities within the PV and MI remit.
* Adhere to, promote, and help enforce applicable SOPs, work practices, and company policies and procedures.
Skills and experience
* Degree in a healthcare‑related or life science discipline, or equivalent relevant experience.
* Demonstrated experience in PV and/or MI, including vendor and partner management.
* Deep knowledge of EU/UK GVP, ICH requirements and related guidance, with a proven track record of translating legislation into pragmatic, compliant PV and MI processes and vendor oversight.
* Strategic mindset with the ability to work independently and a history of solving complex safety‑related challenges.
* Strong teamwork and communication skills, with the ability to influence and partner effectively across functions (e.g. medical, regulatory, quality, commercial, BD).
* Prior experience in line management is preferred, with an interest in developing and mentoring others.
For a confidential conversation and immediate consideration for a June start date please apply ASAP