The PV Case Processor (CP) is responsible for full global data entry of AE/ADR case reports from various sources into the Global Pharmacovigilance database. This includes entry of all relevant case information into structured database fields in accordance with internal case processing standards, the coding data, where applicable, and the preparation of a case narrative.
Completeness, consistency with company standards and timely processing of case reports must be ensured in order to keep compliance with very strict international ADR reporting requirements and timelines.
Major Tasks of Role:
Promptly and accurately identify, interpret and enter adverse event and all relevant corresponding case information into the global database for serious and non-serious AE/ADR case reports. This must be done in accordance with internal data entry standards and within specific timelines as prescribed by global regulations and SOPs.
Verify, as prescribed by regulatory guidelines, that trade names are correctly translated into INN (International Non-proprietary Name).
Perform accurate coding of incoming serious and non-serious adverse events and other case information using MedDRA terminology.
Perform assessment of cases regarding the global listedness
• Create comprehensive case narratives based on all relevant, related information received from local affiliate and/or from various source documents.
Determine drug-event relationship in non-serious ADR/AE case reports.
Request additional follow up information from local affiliate for the completion of case reports.
Contribute to a continuous improvement of PV system and processes.
Value added to the success of the company:
Contribution to the company’s compliance with global pharmacovigilance regulations and ensures timely and high quality input of standardized data into the continuous monitoring of safety profiles and resulting risk management activities of client medicinal products in his therapeutic area, which are key basic requirements to enable the approval and marketing of pharmaceutical products around the world.
Builds and maintains significant product knowledge regarding dozens of different products and clinical projects in the respective therapeutic area Contribution context:
Part of a global matrix of specialist with frequent contacts to functions within and outside the Pharmacovigilance organization. Strong interaction with PV Case Processing Leader and PV Case Evaluators to ensure high medical quality of the ICSRs. Close liaison with pharmacovigilance personnel in in over 60 countries, periodically interacts with internal and external therapeutic teams relevant to the incumbent's assigned therapy area and GPV internal functions (PV Systems, compliance group, QC group, training, and standards)
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