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Head of Pharmacovigilance

A Top 20 Pharmaceutical company is looking for an experienced Pharmacovigilance Manager to join them on a permanent basis for a Head of Pharmacovigilance role.

PRIMARY DUTIES

  • Lead the strategy for the UK&I PV operation and manage a small but specialist PV group.
  • Collaborate with other Affiliate PV teams and PPS to share best practice and contribute to regional/area/global projects and other initiatives.
  • Maintain oversight of all aspects of the performance and functioning of the PV system, including compliance with local regulations, internal company timelines/standards and partner/service provider compliance.
  • Act as the key Affiliate contact for internal PV audits, audits of affiliate service providers/third parties and Regulatory Authority PV inspections.
  • Maintain awareness of any local Regulatory Agency safety request and liaison with Regulatory Affairs to enable timely notification to global RA and PV teams and appropriate response to requestor.
  • Negotiation, development and maintenance of PV-related agreements and contracts with partner companies/vendors, working with PPS to ensure conformance to global standards.
  • Ensure training of all affiliate personnel (including global or area / regional staff based at the Affiliate) and affiliate service provider staff on relevant PV responsibilities at least annually, with appropriate documentation.
  • Ensure the scheduling of locally required Periodic Safety reports (clinical and post-marketing), and submission to Regulatory Authority, Ethics Committees and Investigators as required in accordance with the due dates.
  • Ensure a robust PV system is implemented in line with current GVP, local applicable legislation and corporate QA documents

QUALIFICATIONS / EXPERIENCE REQUIRED:

  • Life science degree
  • Previous and extensive experience in Pharmacovigilance.
  • Previous line management and UK affiliate level experience whilst not mandatory would be an advantage.
  • Effective decision maker who possesses the ability to assess impact of actions taken locally on the global PV system.
  • Strong influencing skills with the ability to explain and defend a position which is in the best interests of patient safety.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales