PE Global is currently recruiting for a Drug Safety Specialist (PV) for a leading multi-national Pharmaceutical client based in High Wycombe.
POSSITION SUMMARY:
Ensure the pro-active Benefit Risk Management throughout product life cycle translating global safety data to insights and actions tailoring to local specificities and needs.
Support activities related to safety reporting requirements as required by Marketing Authorization Holders (MAH) and/or study sponsor, as applicable.
KEY RESPONSIBILITIES:
- Establish Product knowledge with focus on safety profiles, Therapeutic Area and Disease Pathway knowledge supporting the needs of the local Medical and Marketing organization in collaboration with the International Medical Safety leader or MSO and the Local Safety Officer (LSO) if applicable
- Act as safety expert in cross-functional team meetings and perform training on safety relevant aspects, as appropriate;
- Provide Risk Management Plan status updates;
- Provide medical input and insights for aggregate reports;
- Support LSO to undertake local review and ensure the submission of Periodic Safety Update Reports (PSURs/DSURs) if applicable.
- Management of local PVAs and ensure local implementation, including LSU training and adherence to PVAs
- Report regulatory requirements for MAH and/or study sponsor as applicable as per process.
- Support the review of new/revised safety regulations (for drugs and non-medicinal products in scope of responsibilities), evaluation of the impact on local processes and notification of appropriate global and regional groups via central PV policy tracker about changes in local regulatory safety including cosmetics and medical device safety reporting requirements
EDUCATION AND EXPERIENCE:
Interested candidates should submit an updated CV.
Please click the link below to apply, call Amparo on +44 2039 669 800 or alternatively send an up to date CV amparo@peglobal.net
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