Pv Specialist

4 days ago

London, United Kingdom PE Global Full time

**PE Global is currently recruiting a PV Specialist for a 6-month contract role with a leading multinational biopharma client based in London. Hybrid role.**

**Responsibilities**
- Responsible for execution of local PV processes and activities in alignment with PV systems and their associated Quality Management System, following department SOPs, company Policies and Procedures and country legislation.
- Responsible for day-to-day adverse events case management including case intake and follow-up activities in accordance with PV procedures and country regulations.
- Responsible for the intake of cases received from the designated point of contact, Vendors, and Business Partners for Individual case safety reports (ICSRs) including tracking and translation to English and forwarding of information to the Data ManagementCenter. He/she also perform ICSR acknowledgments and reconciliation activities.
- Performs reconciliation activities for PV cases received from local operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners (as applicable) and processes the reports in accordance to local procedures/ PV legislations.
- Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.
- 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 and supports audits of business partners/vendors as directed by their manager.
- Assists in developing local procedures (in compliance with regional and global standards) for the department, to ensure quality PV data and evaluates processes for potential improvement in efficiency and effectiveness.
- Liaises with the local business units to keep them apprised of safety activities and provide input on strategic decisions (i.e., new clinical trials, product launches, etc.) with Management oversight.

**Requirements**:

- A health, life science, or medical science degree or equivalent by education / experience.
- A minimum of 1 years of industry experience in pharmacovigilance.
- General knowledge of PV regulations within his/her assigned country and be an expert in PV processes/activities.
- Strong communication and time management skills and can work independently with mínimal supervision.

Please click the link below to apply, call Alba on + or alternatively send an up to date CV

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