Our client is looking for a Drug Safety Associate to join their Drug Safety Team.
Reporting directly to the Head of Drug Safety, you will be responsible for managing and processing safety reports between the clients affiliates and Global Drug Safety. You will be assigned as the main person responsible for some of the affiliates and your tasks and responsibilities will include, but not be limited to, the following:
- Receipt, tracking and triage of safety reports
- Coordination and/or conducting of routine follow-up activities in countries
- Tracking of inbound and outbound communication related to individual safety cases
- Coordination of case reconciliation with affiliates
- Compliance metrics of reporting to Global Drug Safety
- Development and maintenance of Drug Safety training materials
- Conducting and tracking of trainings for affiliate staff
- Liaising with Medical Affairs compliance to create and update Procedural Documents
- Participating as Subject Matter Expert in audits and inspections at the affiliates
- Implementation and ensuring timely closure of CAPAs and support affiliates with CAPA management
- Streamlining processes and compliance with the Global Drug Safety team
- Maintaining close collaboration with different sources of safety reports such as Quality Assurance, Medical Information and Special Program Responsible
The ideal candidate would hold a university degree in pharmacovigilance or the life sciences field in addition to the following experience:
- 1-2 years working experience in Drug Safety including experience in post marketing surveillance / drug safety operations
- Excellent user of Microsoft Office (Word, Excel, PowerPoint, Outlook)
- Experience in drug safety database, preferably ARISg is preferred
- Experience in training, audits and inspections is preferred
The role will be based at the clients Cambridge office.
You must have strong communication skills orally and in writing and good analytical skills. You should be organised and accurate in your approach, with a good sense for prioritisation and the identification of critical situations from a drug safety perspective. You are able to maintain good working relationships with affiliates and headquarter employees, work effectively in cross-functional teams.