Pharmacovigilance Scientist (remote-based)
- Experience Level
- Experienced (non-manager)
Hobson prior are seeking a Pharmacovigilance Scientist to join a pharmaceutical company focused on the discovery, development, and affordable treatments for diseases. This role will be on a permanent position based in Salisbury however you will be required to work remotely.
- Manage drug safety meetings.
- Maintain a program plan of all activities and deliverables related to drug safety. Synthesize such plan in an intranet "landing page" for all matters related to drug safety.
- Manage the external PV services provider and account for the timely execution of contracted activities.
- Ensure any PV agreements/Safety Data Exchange Agreements with business partners comply with PV standards and are implemented and followed.
- Monitor compliance with regulatory and company standards for safety data management.
- Conduct root cause analysis of procedural deviations and implement CAPAs as required.
- Maintain a pristine book of records of PV activities at the disposal of regulatory auditors.
- Support internal PV audits and regulatory inspections.
- Author or coordinate the authoring and review of PV-related documents: DSURs, PSURs, SMPs, SAE reconciliation plans, RMPs, RSIs.
- Design and perform analyses of safety information for signal detection.
- Educate the organization on critical developments and regulatory guidance related to drug safety.
- Represent drug safety in product team meetings and all activities where drug safety is critical to the success of the company and its products.
- Actively pursue continuous improvement of the PV system, maintain up-to-date knowledge of international PV requirements, and complete assigned training on time.
- Graduate-level degree in life sciences or Masters in Drug Safety.
- Qualification in project management.
- Successful track record in being responsible for a large part of the activities defining the role.
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.