Senior Manager, Pharmacovigilance & Medical Information 12 month FTC

About the role

The Senior Manager, Pharmacovigilance and Medical Information will be responsible for leading the provision and coordination of Pharmacovigilance (PV) and Medical Information (MI) activities for CNX Therapeutics Ltd (CNX) and its subsidiaries, closely coordinate activities with the UK/EU QPPV, vendors & Business Partners and ensure CNX and its subsidiaries are compliant with local PV legislation and the applicable Codes of Practice.

The role requires being the subject matter expert on PV and MI; acting as the main point of contact for our vendors. You will be confident making decisions, take real ownership of your work and thrive in a fast-paced environment where priorities can shift quickly.

You will also be highly organised, able to juggle multiple projects simultaneously and be proactive in driving tasks forward with minimal supervision.

Core role responsibilities

• Act as the main point of contact for all PV and MI related activities


• Coordinate with third-party PV and MI vendors and provide support in overseeing their compliance with contracts and relevant regulations


• Work closely with and support the appointed UK/EU QPPV to ensure oversight of all required PV processes


• Create and maintain PV and MI vendor agreements, including budget responsibilities for such agreements


• Review agreements created by other functions which impact PV


• Review and approve the UK/EU PV System Master File


• Monitor PV and MI vendor KPIs and metrics


• Review and approve MI standard responses and provide support to MI vendor for second line MI enquiries as required


• Create and maintain safety data exchange agreements (SDEAs) as required


• Collaborate with business partners to ensure that SDEA provisions are being adhered to


• Review, revise and author PV and MI SOPs and associated quality documents


• Proactively review and critique SOPs to support continuous improvement initiatives


• Ensure compliance with the General Data Protection regulation (GDPR) in relation to PV and MI data processing


• Act as the lead in PV audits and inspections of CNX


• Perform/maintain oversight of PV audits of business partners and PV/MI vendors


• Perform due diligence from a PV and MI perspective for potential future acquisitions


• Lead on PV and MI integration activities following mergers and acquisitions

Ethical and compliance responsibilities

• Live the CNX Values. Maintain high standards of ethics and support the company in its efforts to have a pioneering approach to environmental, social and governance (ESG). 


• To follow, promote and enforce relevant SOPs, Work Practices, and Company policies and procedures.  

Required skills and experience

• Educated in a health care related or life science field or equivalent demonstrated experience is required


• Demonstrated capabilities in PV/MI vendor and partner management


• In‑depth knowledge of EU/UK GVP, ICH requirements with the ability to operationalise legislation into compliant PV and MI processes, vendor oversight, and audit readiness


• A strategic thinker with the ability to work independently and a history of solving complex safety challenges


• Excellent teamwork and communication skills, with the ability to influence and partner effectively with cross-functional stakeholders


• Previous experience in line management is preferred