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Senior Regulatory Scientist

3 months ago

Hatfield Hertfordshire, United Kingdom Planet Pharma Full time

Title: Senior Pharmacovigilance Operations Scientist Company: Global Pharmaceutical Company
Hatfield, UK (Hybrid Role)

We are currently seeking an experienced Pharmacovigilance Operations Scientist to join our dynamic team based in Hatfield, UK. In this role you will be working with a global pharmaceutical client and be responsible for for the PV Alliance Management process for the companies EMEA region. The senior PV Operations Scientist also supports, leads, and partakes in company business initiated projects and other ad hoc activities where required.

Ensure all EEL managed Safety Data Exchange Agreements (SDEAs) are prepared, reviewed, and revised as required in line with corporate and regional controlled documents (CDs) and/or changes in requirements and that the SDEA repository and associated documentation is maintained.
Ensure the relevant internal stakeholders are informed of the new or revised final SDEAs and where applicable, assist in the implementation
Provide support for the Regional Safety Office as required, including during audit/inspection preparations and ad hoc support with ICSR case processing activities
Provide support for QPPV office by contributing relevant information for the update of the PV System Master File (PSMF)
Demonstrated experience in a Pharmacovigilance role.
Prior experience with SDEAs and building relationships with PV partners.
In depth knowledge of Pharmacovigilance regulatory reporting requirements in European countries.

Apply directly to this job ad or email your CV to eadem@planet-pharma.co.uk Please include the job title " Pharmacovigilance Operations Scientist " in the subject line and we can arrange a confidential call to discuss the position in further detail.