I'm currently looking for a Senior Pharmacovigilance Officer to join a leading Healthcare business based in the Hertfordshire region. As the Senior Pharmacovigilance Officer you will be responsible for the following:
KEY DUTIES AND RESPONSIBILITIES:
Your duties as Senior Pharmacovigilance Officer will be varied however the key duties and responsibilities are as follows:
1. Receipt, triage, Data entry and Quality review for serious or adverse events of special interest as per protocol, originating from sponsored global clinical trials.
2. Generating follow up queries and reporting of clinical trial cases electronically. Also responsible for unbinding of cases for regulatory reporting purposes.
3. Periodic communication with CROs, Clinical Development team and internal Global Product Safety & Risk Management team about study progress, maintaining study tracker and individual study folders.
4. Assisting with authoring of Standard Operating Procedures (SOPs) & Manuals and updating existing SOP's related to PV Operations and Clinical Trials. As well as Assisting the Compliance team in maintaining and tracking clinical safety compliance.
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. Academic background in Pharmacy or Health Sciences.
2. Proven industry experience within a Pharmacovigilance position in the Pharmaceutical industry.
3. A working knowledge and practical experience of Clinical Trials and Clinical Trial case management.
Key Words: PV, Pharmacovigilance, Clinical Trial, Quality, Product Safety
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.