Job Reference: J5631473
Updated On: 10/05/2019
Status: Open to Applications
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Role OverviewAn exciting opportunity has become available for an experienced Senior Pharmacovigilance Officer with hands on of experience of Risk Evaluation to join a leading Pharmacovigilance Consultancy based in the Essex area. As the Senior Pharmacovigilance Officer you will be responsible for signal detection, evaluation and risk management activities.
The Senior Pharmacovigilance Officer will provide scientific review and interpretation of safety data for the preparation and authoring of aggregate reports including Signal Evaluation Reports, PSURs and RMPs.
Key Duties and ResponsibilitiesYour duties as the Senior Pharmacovigilance Officer will be varied however the key duties and responsibilities are as follows:
1. Prepare and author aggregate reports including but not limited to Periodic Safety Update Reports, risk management plans (RMPs), addenda to Clinical overviews (ACOs) and Clinical Expert Statements (CES). You will also prepare and author signal detection reports.
2. Evaluate relevant literature articles to aid in the assessment of the risk-benefit profile of a medicinal product.
3. Communication and collaboration with internal and external customers and prepare and maintain client PV System Master file (PSMF). You will assist in client management activities to set-up clients and maintain documentation.
4. Highlight any areas of concern/discrepancies in the ADR and Signal Management arenas to the Cumulative Reports Team Leader.
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. Pharmacology, Pharmacy, Pharmaceutical Science etc.) in addition to experience of Pharmacovigilance activities and regulations.
2. Proven Pharmacovigilance industry experience with experience of Signal detection and / or risk management planning.
3. A working knowledge of aggregate report writing including Periodic Safety Update Reports (PSURs), Signal Evaluation Reports and / or Risk Management Plans (RMPs).
Key Words: Pharmacovigilance | Drug Safety | Aggregate Report | PSUR | Periodic Safety Update Reports | DSUR | Signal Evaluation | Signal Detection | Signal Management | Risk Management Plans | RMPs | GVP
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