Project Coordinator (PSMF)
Mary Tilston at CK Clinical is recruiting for a Project Coordinator to join a company in the pharmaceutical industry at their site based in Berkshire on a contract basis.
The main purpose of the role will be to:
- Coordinate the preparation of the Pharmacovigilance System Master File (PSMF) and PSMF Summary in accordance with the assigned schedule and ensure the content of the PSMF is complete by liasing with key contributors to ensure the content is provided in a timely manner, collating the data and circulating for review as appropriate.
- Collaborate as appropriate with personnel from Consumer Medical Safety, PV Legal, Consumer Regulatory, Medical Affairs and other functional groups.
- Maintain tracker of controlled documents for inclusion in Annex E to the PSMF and upload the completed PSMF and PSMF summary, supporting QPPV oversight of the submission as well as ensuring that contributing documentation is archived in accordance with the SOP.
Further responsibilities will include:
- Assisting the office of the QPPV with document management and archiving including the upload of documents into the system and as needed schedule meetings, take minutes and provide general additional documentation support to the QPPV office.-Coordinating data received from various global sources and collate in a logical format to ensure legibility and completeness of the PSMF.
- Maintaining tracker of requests for the PSMF Summary
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Educated to degree level or above in pharmacy, bioscience, nursing or a related field.
- Previous pharmaceutical industry or drug safety experience would be desirable.
- Excellent customer service, tracking, coordinating and project management skills with good communication and organisation skills as well as strong computer (Microsft Word, Excel and Powerpoint and Visio) skills.
This is an excellent opportunity to join one of the leading global pharmaceutical companies with great potential and opportunities to develop your career.
For more information or to apply for this position, please contact Mary Tilston on 01438 768717 or email email@example.com. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL31735 in all correspondence.