Pharmacovigilance (PV) Specialist
Our global pharmaceutical client based in Moorgate, London is recruiting a PV Specialist to join their busy team. The role is to start ASAP and is an excellent opportunity to work for a growing organisation. This is a temporary contract role initially signed off for 6 months with a possible extension and offers an hourly rate of £17.00 - £28.46 per hour depending on experience. You will be entitled to 25 days holiday plus 8 Bank Holidays, pro rata.
This role offers Hybrid working, so the successful candidate will be home/remote based for 3 days per week and will also be expected to work on site in London 2 days per week, but can be fully office based if the candidate wants
Our client is looking for people with previous adverse event reporting experience and ideally people who have already worked on a database which is a web-based COTS (Commercial Off-the-Shelf) application developed by an external vendor RxLogix (the database is called PV Intake).
The PV Specialist reports to the Country PV Lead / PV Associate Director and is responsible for PV activities (as delegated/assigned by their manager) which may include but are not limited to: PV Intake activities (including conducting reconciliation and follow-up), Individual case safety report (ICSR) and aggregate submissions, supporting audits and inspections and related readiness activities, authoring local SOPs, local training, escalation of safety issues, and archiving and is able to perform these tasks with minimal supervision. PV Specialist may undertake other additional activities including projects with oversight by their manager.
- 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 Management Center. 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.
- Provides training to local PV staff, company personnel, distributors, vendors, and business partners as instructed by their manager.
- May be assigned responsible for ensuring PV language is included in local agreements and ensuring maintenance of BDLM with respect to local and regional contracts.
- Proactively identifies procedural gaps and challenges and implements solutions in collaboration with affected stakeholders.
- 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
The incumbent 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. He/she should have a minimum of 1 year industry experience in in pharmacovigilance. He/she 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.
- Drug Safety
- Regulatory Affairs
Bank or payment details should never be provided when applying for a job. For information on how to stay safe in your job search, visit SAFERjobs.Report this job
"Office Assistant jobs in London"
'Saved search name'