Compass Life Sciences are partnered with an exciting and cutting edge CRO at the forefront of research across a wide variety of sectors and Pharma companies. Due to an ever-expanding portfolio and the increased general demand across the life science sector, our client is now actively seeking a Senior PV Officer 1 to support PV management in ensuring day to day operations are completed to a high standard.
Owing to the seniority of the role, the Senior PV Officer is expected to perform all duties to an exceptional level; the applicant will be expected to lead by example, and ensure quality is upheld throughout the company. The Senior PV officer will regularly liaise with Senior members of the team, and will take a pro-active and professional approach throughout all aspects of the role.
Main Responsibilities
- Triage and QC sign-off of AEs and ADR reports.
- Knowledge and use of the pharmacovigilance database for processing of Adverse Events (AE) and Adverse Drug Reactions (ADRs).
- EudraVigilance reporting and reporting of expedited cases as appropriate.
- Log & enter ICSRs accurately into the safety database
- Accurate and timely QC of ICSRs
- Updating and adding clients' products to the xEVMPD (Extended EudraVigilance Medicinal
- Product Dictionary).
- Ensure that ICSR documentation is correctly stored within the company documentation system
- Review of literature searches and assessment of data for safety signals and ICSRs.
- Provide advise to enquirer for all MI queries
- Highlight areas of concern/discrepancies to the Operational Group Lead when related to ICSRs
- Acquire and maintain an up to date knowledge of global safety regulations for medicines
- Manage and keep up to date a personal training record
- Performing new tasks as necessary to support the Department
- Act as a deputy client manager for clients and colleagues respectively.
- Prepare and maintain client PV Systems Master file (PSMF).
- Communication with internal and external customers.
Skills
- Able to process and QC all types of ICSRs
- To have a good understanding of Pharmacovigilance
- Able to perform and review literature searches for adverse events
- Able to answer MI enquiries
- Able to create FAQs and SRD for MI enquiries
- Ability to complete registration and update company and user information in EV and XEVMPD
- Understand aggregate reporting and signal detection
- Knowledge of client management
- Ability to identify and author CAPA
Owing to the seniority of the role, a science degree and over 2 years' experience within Pharmacovigilance is essential.
This is a hugely exciting role, with great potential for development and promotion within an exciting company who are rapidly expanding across all Pharma sectors.
If you wish to apply, please contact David Jolley on +44 (0) 2393877358 or at [email protected]
