Compliance Manager - Based Hertfordshire (Head Office)

  • East of England/Anglia,East Midlands,London,South Central
  • Exceptional salary + benefits on offer!
  • Ref: 7128

About the Job

Evolve are recruiting for a global Pharmaceutical company with a new opportunity to work as a Compliance Manager from their head office based in Hertfordshire. You will be responsible for ensuring accurate and strategic scientific and clinical communications across our clients’ products in UK and Ireland.

Evolve is a leading UK recruitment and contract sales organisation (CSO), operating within the Pharmaceutical, Healthcare and Medical Device sectors. We offer a highly comprehensive range of permanent recruitment and flexible contract sales solutions. Please do not hesitate to get in contact with us on 0113 457 0777.

Role Responsibilities

  • Work closely with Business Area Medical team to maintain a high level of scientific and clinical knowledge on products.
  • To be a medical reviewer/signatory for the company materials and ensure medical accuracy and compliance with the ABPI Code of Practice and IPHA Code of Practice.
  • Appraising promotional and non-promotional documents for clarity of messages and medical accuracy, including sourcing references for promotional and educational materials on request.
  • Close collaboration with BA Medical department and alignment with BA Medical strategies.
  • To be the local responsible person for implementation of local pharmacovigilance activities. To act as the local PV Manager and execute all affiliate PV duties including delivering annual PV training to all employees, maintaining Pharmacovigilance Agreements with partners and collating and reporting PV reports from local studies. (Main PV activities are outsourced and under the oversight of the global company).
  • To be the responsible person for implementation of local regulatory activities including implementation of changes to the SmPC and abbreviated prescribing information, liaison with local marketing authorisation holders of marketed products and liaison with outsourced regulatory agency. (Main regulatory activities are outsourced and under the oversight of HQ).
  • Ensure product information is provided to external drug information providers (such as BNF, MIMS, Electronic Medicines Compendium, Medicines.ie) and these providers are updated with new information in a timely manner.
  • To have oversight of the development, implementation and training of company policies and procedures to meet statutory, Code, quality and business requirements for all aspects of promotional and non-promotional activities.
  • To work with the Business Area Medical Team and other relevant personnel to write and update UK-specific SOPs as required. Ensure appropriate training of these SOPs to relevant personnel.
  • Act as the UK & Ireland Co-ordinator: According to relevant corporate procedures, maintain an overview of steering documents applicable to the company together with individual job roles; ensure relevant documents are distributed for training purposes with respect to individual job roles; facilitate access for users within the UK and Irish affiliates; assist users, as required and participate in corporate Co-ordinator meetings and activities
  • Under the direction of the Business Area Medical Team, perform regular audits to ensure SOPs and processes are understood and followed. Develop and complete CAPAs as appropriate.
  • Update and maintain list of Company signatories for UK/Ireland and ensure MHRA & PMCPA are notified of any updates.
  • To be responsible for coordinating the review of all websites under the responsibility of the UK/Ireland business unit, and the maintenance of the company websites.
  • Adhere to all company policies and procedures including but not limited to Code of Conduct, fleet, IT and confidentiality.
  • Ensure compliance with the ABPI and IPHA Codes of Practice.
  • Any other reasonable duties as required from time to time.

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