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An exciting opportunity for an experienced Pharmacovigilance specialist has become available within a 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.
2. Perform QC checks and Signal Detection management as well as agree Pharmacovigilance contracts with 3rd party suppliers.
3. Assist with the generation and submission of PSURs in adherence with UK / EU requirements.
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.
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. A working knowledge and practical experience with Adverse Drug Reaction (ADR) case reporting, PSUR's and MedDRA coding.
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.