Hobson Prior is currently seeking a PSMF Manager for a leading global biopharmaceutical company that has been inventing for life for more than a century. This position will be accountable for maintaining the oversight over the structures and performance of the pharmacovigilance system, especially development and maintenance of the global PSMF.
- Accountable for authoring global Biopharma PSMF and ensuring ‘up to date’ and accurate content.
- Writing the body text and annexes.
- Consolidate PSMF data from contributors for body text and annexes.
- Ensure review, documented QC, approval and publishing of the PSMF according to Biopharma’s procedures.
- Keep up-to-date of changes to the EEA regulations for PSMF and ensure the organisations Biopharma’s PSMF stay compliant with these.
- Develop, maintain and improve the processes and procedures related to and the management of the PSMF.
- Proficiently lead and drive the regular and ad hoc updates of global Biopharma’s PSMF and ensuring timely updates by the end of each quarter and annexes updates on a bi-monthly regular basis.
- Guide and influence cross functional contributors inside and outside GPS to provide timely and high-quality data.
- Make sure that any requests for the company Biopharma PSMF from Health Authorities and auditors are met to the expected quality and in a timely manner.
- Personal effectiveness and performance driven.
- Organizational, prioritization skills.
- Pharmacovigilance quality systems, legislation.
- In-depth PV knowledge (clinical trials, post-marketing).
- Hands on experience in writing and maintaining a pharmacovigilance system master file.
- Practical experience in Electronic Data Management Systems like CARA.
- Quality management background.
- Minimum of 4 years in Pharmacovigilance.
- English (German would be admirable).
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back 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.