IPV Case Management Specialist
- Experience Level
- Experienced (non-manager)
Are you a Drug safety/ PV professional with 3-4 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 Specialist to ensure Individual Case Safety Report (ICSR) case processing and related activities are carried out to enable compliance with applicable regulatory requirements, company procedures, at a local/regional level or global level, and in compliance with provisions of PV agreements with business partners .
- Receipt, assessment and processing of incoming safety information from multiple sources, both internal and external to the Company.
- Support timely submission of aggregate safety reports (e.g. DSUR, PSUR etc. applicable) to applicable health authorities, in collaboration with local medical safety input (as applicable).
- Enter relevant/required safety data into the Global Inbound Receipt System (GIRS) from spontaneous, clinical trials and other solicited sources.
- Continual monitoring, assessing the reportability of ICSRs due for regulatory reporting, and submitting to respective Competent Authorities (CAs) / Business Partners (BPs), as applicable.
- Vendor training, on-going vendor support on a case level (daily or as required), case review, and vendor oversight (daily or as required)
- Local literature screening for ICSRs and potential safety signals (in consultation with local medical safety as needed).
- Liaise with applicable stakeholder to support case processing requirements for Medical device vigilance, materiovigilance, or cosmetovigilance (as applicable).
- 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