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PV Processes & Training Manager

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  1. Drug Safety / Pharmacovigilance
Date Posted19 Mar 2020
Do you relish the opportunity to work with a global biotech organisation based in Berkshire? If yes, then this is the assignment for you!

Our client that specialises in the treatment and prevention of serious human medical conditions is currently seeking the expertise of a PV Process & Training Manager. 

The successful candidate will be responsible for updating and teaching new pharmacovigilance processes. 

Essential Duties and Responsibilities for this PV role include, but are not limited to, the following: 

Define and support implementation and improvement of PV processes in accordance with GVPs, FDA and international PV legislation including the preparation of corresponding PV Standard Operating Procedures/ Work Instructions/conventions documents and associated training materials in close collaboration with the EU QPPV/local QPPVs and the relevant subject matter expert/department director.  Ensure alignment of PV documentation with both regulatory requirements, internally policies as well as quality manuals. 

Ensure improvement and updating of PV and PV related processes and procedures as required by CAPAs, new regulatory requirements and regulations.

Maintaining track of all controlled documents relevant to PV activities. Act as a lead contributor for allocated sections of the PSMF Core and its Annexes to ensure compliance of the PV System. 

Prepare and maintain PV training matrix for employees. Support training of conventions in close collaboration with Head of PV Ops and relevant subject matter experts. Support the preparation of PV training materials and ensure that, the relevant training is assigned to PV staff and other stakeholders as appropriate.  Ensure appropriate PV training documentation is in place.

Desirable Experience: 

  • Strong communicator with excellent English language skills, both written and spoken, ideally demonstrable experience in a medical/scientific writing.
  • Good networking and team skills for successful cooperation with internal and external customers.
  • Excellent negotiation, conflict resolution, decision making, problem solving and presentation skills.

To be considered for this opportunity please apply!

The candidate must have the rights to work in the location stated in the job advert.

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