Job Reference: J5632250
Updated On: 10/10/2019
Status: Open to Applications
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Role OverviewAn opportunity for an experienced Senior Pharmacovigilance Officer has opened within a leading Pharmaceutical company based in the Buckinghamshire area. As the Senior Pharmacovigilance Officer you will be responsible for the preparation and review of Pharmacovigilance aggregate reports including Periodic Safety Reports ( PSURs ), Risk Management Plans ( RMPs ) and Signal Detection activities.
Key Duties and ResponsibilitiesYour duties as the Senior Pharmacovigilance Officer will be varied however the key duties and responsibilities are as follows:
1. Lead safety review activities including Signal Detection and Signal Management to assess changes to risks associated with the company's products.
2. Preparation of Periodic Safety Update Reports ( PSURs ) for the MHRA and EMA as well as the preparation of Risk Management Plans ( RMPs ).
3. You will review outputs from Global Literature searches and quality check information for ICSRs or relevant safety information.
4. QC and triage Pharmacovigilance reporting in accordance with regulations, SOPs and safety data exchange agreements.
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 including previous experience within a Pharmacovigilance position.
2. Proven industry experience of Aggregate reporting including Signal Detection and Risk management Plan experience
3. A working knowledge and practical experience with Literature searches and PSUR writing will benefit your application.
Key Words: Pharmacovigilance | Drug safety | Periodic Safety Update Reports | PSUR | Risk Management Plans | RMP | Signal Detection | QC | Triage | ICSR |
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