Our client, a leading pharmaceutical company, is recruiting for a Pharmacovigilance Manager to join its team in Berkshire, UK. The company is one of the top 10 pharmas in the world, operating in many continents and employing thousands worldwide.
- Line manage UK Drug Safety Scientists to ensure that Drug Safety Reporting activities are carried out to ensure the comapny complies with Good Pharmacovigilance (PV) Practice regulation.
- Deputise for Senior Drug Safety Manager
- Call handling: Answer inbound calls relating to patient data collection programs, third party partner contracts/ agreements
- Query handling: Respond to queries escalated by the DSS / Senior DSS in a timely way obtaining input from CSTL/LSO as necessary
- Monitor regulatory websites and subscribe to relevant regulatory alerts to maintain continual awareness of regulatory a reporting change that affects the UK and Ireland and informs CSTL/LSO to ensure compliance.
Additional Compliance Activities
- Review effectiveness of established CAPAs
- Trend deviations and implement CAPAs as necessary
- Supports coordination of internal and external audits and inspections
- Complete all assigned training in a timely manner
- Train company staff and/or third party partners with respect to pharmacovigilance
- Support CSTL/LSO in responding to ad hoc requests as required
- Act as key point of contact for studies or partner contracts
- Maintains oversight of aggregate reporting responsibilities, periodicity and submissions
- Contributes to global, regional and/or local projects
- Write, review, validate and implement local procedural documents and verify adherence
- Provides the Office of the Qualified Person (QP) for PV any local information required to ensure compliance
Key Line Management Activities
- Regularly coach/mentor all direct reports
- Provide/resource training provision to meet development needs of line report/s
- Conduct recruitment interviews/assessments as required
- Check that all direct reports have completed required compliance training including HCC, Drug Safety & complaints within 1 month of joining the company and annually thereafter
Key Compliance Requirements
- Complete all allocated compliance and SOP training in a timely way e.g. annual Drug Safety Training, and act according to guidelines etc., stated within these programmes and documents
- If commissioning contractors or third party organisations, put contracts in place and provide training so that these individuals also act in accordance with company HCC requirements when interacting with Healthcare Professionals and report adverse events and complaints (as above).
Education and Experience:
- Life science degree or nursing qualification
- Proven ability to organise workflow activities and manage multiple issues
- Awareness of and familiarity with industry principles of pharmacovigilance, drug development and pharmacology
- Sound knowledge of Global and Local SOPs
- Sound knowledge of GMS database systems
- Excellent verbal and written communication skills with ability to negotiate and communicate with internal and external customers
- Ability to establish and maintain open relationships within the organisation and with authorities
- Demonstrable knowledge of all local PV requirements and of Global aspects of drug safety
- Demonstrated pharmaceutical industry experience including solid experience in a PV responsibility role
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kevin Hansberry on +44 207 4400 636 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.