We are currently recruiting for a Senior Pharmacovigilance Scientist to join an established Pharmaceutical company in Hertfordshire, UK. The position will require you to line manage the Pharmacovigilance Scientists.
As a Senior Pharmacovigilance Scientist, you will play a major role the day-to-day functioning of the Pharmacovigilance Department with regards to Aggregate Safety Reports. You will manage and oversee the workload of aggregate safety report coordination, data migration, SAE reconciliation and training of staff members.
Further key responsibilities of this Senior Pharmacovigilance Scientist role include:
- Supporting the Local Safety Officer, the Regional Safety Officer and General Safety Officers in their functions.
- Manage and appraise Senior Pharmacovigilance Scientist(s) and Pharmacovigilance Scientists<p>
- Acting as back up for the Head of Pharmacovigilance Operations in their absence.
- Ensuring compliant expeditious reporting of Pharmacovigilance Reports to regulatory authorities.
- Overseeing and co-ordinating schedule of aggregate report.
- Managing the production of aggregated Safety Reports including scientific writing of sections of the report while seeking General Safety Officer / medical input where required for designated products.
- Acting as a product specialist and aid in the scientific review of documents, including but not exclusive, Investigational Brochures, final study reports and protocols for designated products.
- Participating as a key member in signal generation process including analysis of similar medical events.
- Providing support to the PhV Physicians in the evaluation of Pharmacovigilance Reports.
- Ensuring that such activities are performed to high standards of quality and timeliness in line with the best industry standards.
- Performing follow-up activities for Pharmacovigilance Reports.
- Coordination and responsibility of triage of in-coming serious Pharmacovigilance reports in accordance to their seriousness, expectedness and determining reportability.
- Performing SAE reconciliation and managing the SAE reconciliation process for their products.
- Ensuring correct and accurate input of source data onto the global AE reporting database.
- Compliance to SOP’s, processes, practices and guidelines and aiming towards excellence<p>
- Reviewing and writing of SOP’s and Working Practices. <p>
- Training of staff to include internal/external presentations (e.g. team training, Investigator meetings, CRO training).
The successful candidate will be educated to degree level or above in a Life Sciences subject. As a Senior Pharmacovigilance Scientist it is also essential that you have proven working experience in pharmacovigilance. Experience in scientific review of documents and writing of aggregate safety reports is also essential for this role.
This is an excellent opportunity for an experienced Pharmacovigilance Scientist to develop their career with a worldwide pharmaceutical organization.
If you believe you can make an impact in this innovative and cutting edge business, then please contact Hendre on Tel: +44 (0)1438 743047 or email me at firstname.lastname@example.org quoting 18931 to indicate your interest. Alternatively, to apply, please click here.
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