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An exciting opportunity for an experienced Pharmacovigilance Specialist to join a Leading Pharmaceutical company based in the Berkshire area. As the Senior Pharmacovigilance Officer you will be responsible for performing Pharmacovigilance activities for all company products as well as training staff in drug safety and product information to ensure the company is compliant with MHRA and EU regulations.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior Pharmacovigilance Officer will be varied however the key duties and responsibilities are as follows:
1. Report all adverse drug reactions from a range of sources as well as adverse events related to company sponsored clinical trials. Perform QC checks on all AEs, prepare PV agreements and handle all partner reconciliations.
2. Perform Signal Detection and management activities as well as the preparation of Periodic Safety Update Reports (PSURs) to UK and EU regulations. Ensure the successful submission of PSURs as well as the generation of metric reports.
3. Support the PV Manager with QA PV strategy. Review internal and external SOPs, contribute to the Pharmacovigilance System Master Files (PSMF), develop audit plans and write Request for Proposals (RFPs) when dealing with Vendors. Raise CAPAs and ensure the general compliance of the Pharmacovigilance team
4. Continuously maintain and enhance the company's knowledge base concerning regulations, directives and guidelines as well as assisting with compliance metrics, monthly and quarterly reports. You will act as the Local Pharmacovigilance Officer (LPO) and the UK point of contact regarding the MHRA.
To be successful in your application to this exciting opportunity as the Senior Pharmacovigilance Officer we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline (e.g. Pharmacology, Pharmacy, Chemistry etc.) with hands on experience working in a Pharmacovigilance / Drug Safety focused position.
2. Proven industry experience in Pharmacovigilance, ideally working directly with EU agencies with a sound knowledge of EU regulations, directives and guidelines.
3. Hands on experience of Signal detection activities, writing of PSURs and participating in audits is vital for your application.
Key Words: Pharmacovigilance | Drug Safety | Associate | Officer | Senior | PV | EU | MHRA | PSUR | Adverse Drug Reactions | ADR | MedDRA | QC Checking | Triaging | Local Safety Officer | Local Pharmacovigilance Officer | CAPA | Audit
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.