Our global Pharmaceutical client based in Hertfordshire is searching looking for a Pharmacovigilance Specialist to join their team on a 6-month contractual basis.
This exciting and global client helps to transform the lives of millions of both human & animal patients in the UK by providing innovative medicines, vaccines, and services. They invest heavily in the professional development of staff whilst also encouraging a healthy work/life balance.
In this role you will ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules so that there is no gap in adverse event reporting and drug safety oversight.
Roles and responsibilities as a Pharmacovigilance Specialist
- Responsible for day-to-day adverse events case management.
- Responsible for the intake of cases received from the designated point of contact, Vendors, and Business Partners for Individual case safety reports (ICSRs).
- Responsible for execution of local PV processes and activities in alignment with PV systems and their associated Quality Management System.
- Performs reconciliation activities for PV cases received from local operating units.
- Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues.
- Supports local PV audits and inspections including readiness activities.
Qualifications, Skills & Experience required as a Pharmacovigilance Specialist
- A degree in health, life science, or medical science.
- Excellent communication skills.
- A minimum of 1 year of industry experience in in pharmacovigilance and/or regulatory affairs.
- Good general knowledge of PV regulations and PV processes/activities.
If you're interested in this role please apply now to be contacted ASAP.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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