CK Group are recruiting for a PV Specialist to join a biopharmaceutical company at their site based in London on a contract basis for 12 months.
Up to £28,46 Per hour PAYE
PV Specialist Role:
- 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 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 Management Center. Will lso 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
- 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.
- 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.
- Must have a health, life science, or medical science degree or equivalent by education
- Experience and be fluent in English (written and spoken) while proficient in local language
- Should have a minimum of 1 years of industry experience in pharmacovigilance.
- Must have a general knowledge of PV regulations within his/her assigned country and be an expert in PV processes/activities.
- The Specialist is expected to have strong communication and time management skills and canwork independently with minimal supervision.
Company: Our client is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. They have an interdependent global manufacturing networkthat's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
Location: This PV Specialist role will be based at our clients European Business Development and Licensing hub in London.
Entitlement to work in the UK is essential. For more information, please contact Dennis on 01438 870011 or email email@example.com. Please quote reference 50515.