Manager, Pharmacovigilance and Medical Information

3 weeks ago

London, United Kingdom CNX Therapeutics Full time

JOB DESCRIPTION


To be considered for an interview, please make sure your application is full in line with the job specs as found below.

Job title: Manager, Pharmacovigilance and Medical Information - FTC

Reporting to: Director, Scientific Affairs

Department: Scientific Affairs

CNX Therapeutics is a European pharmaceutical company dedicated to improving the lives of patients through the supply of essential medicines. We commercialise and distribute a portfolio of speciality brands and hospital products in Europe, in 40 countries worldwide, both directly and through strategic partnerships. Our vision is to become a recognised partner of choice through our commercial excellence, patient focus and presence across Europe.

We want to be Pioneers We may be small, but we’ve got some big goals. That’s why, at CNX, ESG (Environmental, Social, and Governance) isn’t just a fancy acronym; it’s a roadmap to our future success. Why, you ask? Well, it’s because we want the work we do to have a positive impact, on ourselves, on each other, on the world we live in and on the patients we serve.

And guess what? It’s on all of us to do this. So, whether you’re crunching numbers, selling products, moving those products around, maintaining our high ethical standards, or brainstorming new ideas, remember that every small action counts. CNX will do its bit for you through our inclusive and family-friendly benefits and ways of working, supporting your professional and personal growth, so you are empowered to pay it forward every day.

The Role:

Lead the provision and coordination of Pharmacovigilance (PV) services for CNX Therapeutics Ltd (CNX) and CNX subsidiaries and closely coordinate activities with the QPPV, PV vendor and Business Partners.

Lead the provision and coordination of Medical Information (MI) services for CNX and CNX subsidiaries and closely coordinate activities with the MI vendor.

Ensure CNX and CNX subsidiaries are compliant with local PV legislation and the applicable Codes of Practice.

Core Tasks & 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).

Pharmacovigivlance:

  • Be the subject matter expert on PV.
  • Lead on and manage the PV system.
  • Work closely with and support the appointed QPPV to ensure oversight of all required PV processes.
  • Have oversight of all PV tasks.
  • Create and maintain PV vendor agreements, including budget responsibilities for such agreements.
  • Review agreements created by other functions which impact PV.
  • Be the main point of contact for PV vendor(s).
  • Monitor PV vendor KPIs and metrics.
  • Create and maintain PV agreements with Business Partners.
  • Act as the National PV Contact Person for the MHRA as required.
  • Review, revise and author local PV SOPs and associated quality documents.
  • Collaborate with QA on the PV audit plan and lead in PV audits and inspections.
  • Perform/maintain oversight of PV audits of Business Partners and PV vendor(s).
  • Ensure compliance with local PV legislation.
  • Ensure compliance with the General Data Protection regulation (GDPR) in relation to PV data processing.

Medical Information (MI):

  • Be the subject matter expert on MI.
  • Manage, support and be the main point of contact for the MI vendor.
  • Create and maintain MI vendor agreements, including budget responsibilities for such agreements.
  • Review, revise and author local MI SOPs and associated quality documents.
  • Review, and approve standard responses used by the MI vendor.
  • Ensure, compliance with the General Data Protection regulation (GDPR) in relation to data processed by the MI vendor.
  • Monitor MI vendor KPIs and metrics.
  • Ensure compliance with the applicable Codes of Practice.

PV and MI:

  • Support and carry out other tasks as agreed with Line Manager.
  • Perform due diligence from a PV and MI perspective for potential future acquisitions.
  • Perform integration activities for acquired products and assets in line with agreed project timelines.
  • Manage the PV & MI team workload and prioritisation.
  • Escalate issues to the QPPV and Director, Scientific Affairs.

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