Reference Number: JO-2107-472750
IPV Case Management Coordinator
Job Type: Permanent
Location: High Wycombe
Are you a Drug safety/ PV professional with 1- 2 years experience? Are you looking for an opportunity to work for one of the top 5 Pharma companies in the world? If so this role might be for you.
CPL are actively recruiting for an International Pharmacovigilance (IPV) Case Management Coordinator to support the IPV Case Management Team Leads/Associates in all administrative aspects of Individual Case Safety Report (ICSR) case processing and related activities within a country or collaboration network
- Support with telephone call management answer inbound calls from general public, HCPs, internal colleagues to elicit and capture relevant adverse event data
- Provide administrative support for the receipt, assessment and processing of incoming safety information from multiple sources, both internal and external to the Company.
- Enter relevant/required safety data into the Global Inbound Receipt System (GIRS) from spontaneous, clinical trials and other solicited sources
- Support with the provision of safety information/acknowledgements to marketing partners/other third-party partners/Global Medical Safety within the internal and contractual timelines
- Provide administrative support in performing follow-up activities for requesting additional information from multiple sources.
- Provide archiving support for all ICSR related source documents file, maintain and archive all case related materials in adherence with records retention policies
- Provide support with periodic reconciliation activities (e.g. TFUQ/due diligence reconciliation)
- A degree in life, health or pharmaceutical sciences is preferred.
- Proficiency in Medical terminology (local languages).
- Familiarity with global ICSR related global, regional and local PV procedural documents as applicable.
- Computer literate with expert knowledge of the Intake (GIRS) and/or expedited reporting (OST) module(s)
- Ability to prioritize and work to strict timelines daily
- Excellent verbal and written communication skills
- Fluency in local (if applicable) and English language required
- Ability to negotiate and communicate with internal and external customers
- Knowledge and understanding of key legislation applicable to pharmacovigilance
- Proven expertise and experience in pharmaceutical regulations and R&D processes is desirable