Job Reference: J5631180
Updated On: 21/03/2019
Status: Open to Applications
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Role OverviewWe are currently looking for a Senior Pharmacovigilance Officer to join a leading Pharmaceutical Consultancy based North of London in the Essex area. As the Senior Pharmacovigilance Officer you will be a valued member on the Clinical Trial Surveillance team and support the Team Leaders and Manager to ensure the smooth running of the department.
Your main duties will be to mange client interactions as well as the review of aggregate reports. This is in addition to the Triage and QC of case reports from junior members of staff.
Key Duties and ResponsibilitiesYour duties as the Senior Pharmacovigilance Officer will be varied however the key duties and responsibilities are as follows:
1. Processing of Serious Adverse Events (SAE) and Serious Adverse Drug Reactions (SADRs) in addition to the Triage and QC sign-off of AEs, AESIs, SAEs and SADR reports. You will submit to EudraVigilance as well as the relevant regulatory bodies.
2. You will prepare and review Development Safety Update Reports (DSURs) and add client products to the EVMPD (EudraVigilance Medicinal Product Dictionary)
3. You will liaise with clients and act as Client Manager on a range of Clinical Trial projects.
4. You will Monitor changes to the pharmacovigilance guidelines and work with Senior Management to implement the necessary operational changes as well as participating in audits and maintaining SOPs.
Role RequirementsTo 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. Biology, Pharmacology, Pharmacy, Chemistry etc.)
2. Proven industry experience in Pharmacovigilance / Drug Safety, ideally with a focus on Clinical Trial Surveillance.
3. A working knowledge and practical experience with QC and Triaging of case reports as well as experience of aggregate reporting.
Key Words: Pharmacovigilance | Drug Safety | Clinical Trial | DSUR | Development Safety Update Reports | EudraVigilance | EVMPD | Serious Adverse Events | SAE | Serious Adverse Drug Reactions | SADR | Aggregate Reporting
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