Hobson Prior is seeking an experienced PV Specialist to join a dynamic team. This role will be responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies/procedures at a local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners.
Please note that to be considered for this role you must have the right to work in this location.
Job responsibilities:
- Carry out the quality check of the PV cases and ensure that the English translation has been properly performed.
- Keep up to date a local tracker of the individual safety reports.
- Be the subject matter expert at local level on the case management activities.
- Closely follow the respect of the regulatory timelines of the submission of the safety reports to the local health authorities and communicate any potential delay to the appropriate teams.
- Establish and maintain local indicators on the compliance of the safety reports submission.
- Support in local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA (Corrective and Preventative Action) plans as applicable.
- Provide PV clauses to be included within local agreements and contribute to the PSMF with contracts-related information.
- Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage).
Required Qualifications and skills:
- Education: health care science professional or equivalent training.
- Significant training in data management with strong IT skills.
- Proven working years of relevant experience (e.g. case data management, reconciliation manager, vigilance IT project manager…).
- Fluent in English. French as a mother tongue.
- Excellent communication skills and ability to work with cross-functional teams.
- Rigor is a key skill for this mission.
For more information, please contact Will Tyler.
Apply now
If you are interested in learning more or applying to this exciting opportunity then please click 'Apply' and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly please select 'Contact me' at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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