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.
- 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