Pharmacovigilance Project Manager

  • Salary: Competitive
  • REF Number: 00033009
  • Consultant: Mary Tilston
  • Contact: 01438 768 717
  • Date Published: 12.06.2015
  • Closed Date: 17.02.2016
  • Sector:
  • Location: Hertfordshire,
  • Discipline:

Mary Tilston at CK Clinical is recruiting for a Pharmacovigilance Project Manager to join a CRO at their site based in Hertfordshire on 12 months fixed term contract

Your main responsibilities in this role will be to: Provide effective pharmacovigilance consultancy and support for client projects and oversee the development and management of key client accounts.

Further responsibilities will include:

  • Performing the role of the Project Manager for pharmacovigilance projects as assigned by the VP, Operations and Pharmacovigilance, ensuring advice is provided on pharmacovigilance strategy and requirements for investigational and marketed products to pharmaceutical and biotechnology clients.
  • Assisting with establishing clients' pharmacovigilance systems including preparation and/or review of SOPs, safety management plans and pharmacovigilance data management plan.
  • Assisting with maintenance of Company's pharmacovigilance systems including preparation and/or review of SOPs, working instructions and other working tools such as forms, spread sheets and safety databases.
  • Preparation, coordination and review of key pharmacovigilance related regulatory documents for both investigational and marketed products, including the DSUR, PSUR, EU-RMP, PSMF, SDEA.
  • Co-ordination and execution of on-going activities such as literature review, signal detection, project steering committee meetings, liaison with QPPV and local QPPVs, management of labelling documents, interaction with regulatory authorities.
  • When required, manage and support, pharmacovigilance case management activities including SAE case entry, regulatory assessment of SAEs and submission to relevant Authorities
  • Maintaining awareness of regulations and changes to regulations concerning pharmacovigilance. Inform VP, Operations and Pharmacovigilance and QA function of significant changes.

You are required to have the following qualifications, skills and experience:

  • Degree qualified
  • Previous Pharmacovigilance experience

For more information or to apply for this Pharmacovigilance Project Manager position please contact Mary Tilston on 01438 768717 or email MTilston@ckclinical.co.uk

CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL33009 in all correspondence.

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