Global Safety Senior Associate
2 weeks ago
An innovative global pharmaceutical company, based in Uxbridge, is currently looking for a Global Safety Senior Associate to join their team on an initial 12-month contract.
Working within the Global Safety Team you will be responsible for the coordination of all pharmacovigilance post market activities in clinical trials ensuring regulatory reporting compliance. A good communicator and project co-ordinator you will be ableto work across departments and external stakeholders working to deadlines.
**Key Responsibilities**
- Co-ordinate the receipt and management of adverse event (AE) reports as well as liaising with HCPs for complete data and submit safety reports to regulators
- Support the submission of DSUR and PSUR safety reports to regulators and ethics committees
- Oversee safety queries from internal and external stakeholders
- Liaise with Regulatory Affairs as well as Clinical and Medical departments on the submission of safety risk communications
**Requirements**:
- Educated to degree level (Doctorate, Master’s or Bachelor’s)
- Background within post market and clinical trial pharmacovigilance in a pharmaceutical or biotechnology industry
- Great knowledge of requirements and regulations for pharmacovigilance
- Use of ARGUS safety database
- Team player with great attention to detail
- Excellent communication and interpersonal skills
Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Business in relationto this role.
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