Head of Drug Safety
3 weeks ago
**Job Title**:Head of Drug Safety & Information and QPPV
**Salary:** £85K-90K
**Job Type**:Permanent full-time role (37.5 hours per week) (3 days/week in office and 2 days/week at home)
**Location**: Wrexham, LL13 9UF
You will be working from our Wrexham based site which is home to our MHRA approved sterile injectable manufacturing facility.
**Role overview**:
- Overall authority over the pharmacovigilance (PV) system of the Company
- Ensure the PV system is compliant with the legislative requirements and the system is inspection ready at all time
- Point of contact for the authorities concerning PV and authority inspections
- Responsible for writing and maintaining Company’s Pharmacovigilance System Master File (PSMF)
- Review and approve all PV-related documents, e.g. PSURs, RMPs, signal reports
- Oversight over post authorisation safety studies (PASS) and risk minimisation activities
- Implement, conduct & maintain audit schedules (internal PV system & Company’s affiliates/business partners)
- Preparing, hosting and following up on regulatory authority inspections
- Make strategic decisions on PV agreements and serve as the PV expert to review and negotiate PV agreements with business partners
- Drives the operational activities within the department and makes strategic decisions to improve compliance
- Monitor overall compliance within the department and execute CAPAs post audits and inspections
- Point of contact for vendors and service providers
**Role requirements**:
- Life sciences or medical degree (MSc or above)
- Minimum of 10 years of relevant experience, experience of deputy QPPV or QPPV preferred
- A clear understanding of European, international and local PV requirements including Good Pharmacovigilance Practices (GPvP)
- Experience in hosting audits and authority inspections
- Experience working with various internal and external stakeholders
- Advanced compliance management skills
- Line management skills and experience in managing a team
- Excellent communication and interpersonal skills with the ability to communicate complex information
- Organisational skills and the ability to assess priorities
- Meticulous attention to detail
- Experience with PV database
If you’re interested in the role and would like to put yourself forward, please hit **APPLY
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