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
Please note the company is not able to offer sponsorship or relocation assistance for this role so candidates must already possess the right to live and work in the UK to be considered.
If you’re interested in the role and would like to put yourself forward, please hit APPLY.
Candidates with the experience or relevant job titles of Health and Safety Consultant, SHEQ Manager, Health and Safety Manager, Environment Officer, Quality Assurance Coordinator, Quality Advisor, Health and Safety Coordinator, SHEQ Officer, SHEQ Advisor, Health and Safety Advisor, Quality Officer, Environmental Coordinator, Environment Advisor, Health and Safety Officer, Process Engineering Health & Safety Consultant, Health & Safety Compliance, Occupation Health &amp Safety, Chemical Engineering, will be considered for this role.
