Hendre Moolman is recruiting for a Global Pharmacovigilance Regional Head to join a pharmaceutical company in a permanent r
ole in Hertfordshire.
As a Global Pharmacovigilance Regional Head the main purpose of your role you will be to manage Pharmacovigilance / Safety and Medical Information projects in regions (Asia Pacific, Americas, Europe, Middle East and Africa) where the company has a presence, providing medical expertise for Medical, Drug Safety/Pharmacovigilance and other corporate functions.
Further responsibilities of this Global Pharmacovigilance Regional Head position will include:
- Establish Pharmacovigilance function in countries of the applicable Regions.
- Train & support the Local Pharmacovigilance Responsible Person for specific region to perform Pharmacovigilance activities in their respective countries
- Ensure the process set forth by Global Pharmacovigilance including ICSR(s), Aggregate Reports PSUR, DSUR) are written & reported to respective regulators with maintaining the highest level of compliance
- Perform Pharmacovigilance review of protocols, CSR’s, PSUR’s, PADER’s, DSUR’s
- Establish, support & facilitate routine Pharmacovigilance activities such as case processing, aggregate report, and signal detection
- Oversee & perform routine quality checks on the activities that are outsourced to third party vendors on behalf of the company’s Pharmacovigilance function in countries of the applicable regions.
- Train & support the Local Pharmacovigilance Responsible Person for specific region to perform PV activities in their respective countries able Pharmacovigilance
- Settings, appraisal and management of direct line reports
- Support internal & external inspections and audits from regulators & third party vendors
- Support Global Head of Pharmacovigilance with process, structure, budgets and strategy decisions
- Support function of the QPPV in Europe
- Ensure the compliance of Global Pharmacovigilance system by working collaboratively with internal & external company personal
Qualifications, Skills and Experience:
As Global Pharmacovigilance Regional Head you will have the following qualifications, skills and experience
- Graduate/post graduate in pharmacy/medicine/life science with very strong experience in pharmacovigilance
- Direct PV experience or previous experience of clinical research is necessary
- Expertise in a particular medical area preferred
- Experienced in and knowledgeable about clinical development processes
- Knowledge of regional drug authority regulations, GCP, ICH
- Proven ability with high level influencing and negotiation skills
- Excellent communicator with ability to educate and influence decisions through clear written and verbal communications
- Strong organisational skills and detail oriented
- Dedication to quality in all work tasks and deliverables
As Global Pharmacovigilance Regional Head you will be joining a global pharmaceutical company based in Hertfordshire on a permanent role. This exciting opportunity offers a competitive salary and the opportunity to build on management experience.
For more information or to apply for this Global Pharmacovigilance Regional Head position please contact Hendre Moolman on +44 (0)1438 842 970 or email firstname.lastname@example.org. Please quote reference CL25286 in all correspondence.
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