Up to £44000 per annum
over 2 years ago
Senior Pharmacovigilance Officer
A speciality pharmaceutical company in Berkshire is seeking a Senior Pharmacovigilance Officer. This role with will have responsibility for pharmacovigilance for all company products, ensuring company compliance inline with MHRA/EU regulations and to provide training in matters of drug safety and medical/product information.
- Generation of PSURs in line with UK/EU requirements and Maintains PSUR schedule.
- Prepares expedited report and handles AE follow-up requests
- Support PV Manager in developing and executing QA PV strategy and implementing associated Quality Management System
- Contribute to evaluation of corrective and preventative action (CAPA) findings to identify quality-related signals and trends for improvement
- Reconciliation of ADR and MI reporting.
- Contribute to the development and implementation of strategic audit plans for pharmacovigilance activities that include service providers, vendors, business partner, and internal audits
- Experience in EU pharmacovigilance within either a research and development or established products environment
- Case Processing and drug safety report writing experience
- Knowledge of Good Pharmacovigilance Practices (GVP), Good Clinical Practice (GCP), Good Distribution Practices (GDP), and Good Laboratory Practices (GLP)
- Relevant experience in the pharmaceutical industry
- Extensive Compliance, Quality and auditing experience.
Salary and benefits:
- Competitive salary and bonus
- Extensive benefits package