Review, assess and process Lifecycle Safety data and information, across all service lines received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOP’s and internal guidelines. May provide oversight on projects with limited complexities for activities on small to medium service operational projects.
•Triages, tracks, and processes adverse event information in the safety database according to the project plan and SOPs
•Assesses safety data for reportability to regulatory authorities
•Performs duplicate search and data entry in the Argus safety database, as well as MedDRA coding of adverse event terms and medical history, WHO coding of medications, writes descript narratives to summarize the adverse event information received
•Communication (phone, fax, and/or email) with reporters to reconcile discrepant data or obtain missing data regarding adverse events.
•Maintain 100% compliance with project/Sponsor SOP trainings and processes; ensure to meet quality, productivity, and delivery standards per Client and Customer requirements.
•Work volume can fluctuate day to day but based on the information we have for this specific project, it will be very busy and they can expect to process anywhere from 5-7 cases per day (might be more of less, depending on the volume that comes in each day).
Drug safety, Pharmacovigilance, Safety, Medical information databases, Medical terminology, Data entry
Top Skills Details:
Medical Information Specialist
Additional Skills & Qualifications:
MUST HAVE 1: Bachelor’s Degree or educational equivalent in a Scientific or Healthcare discipline
MUST HAVE 2: 1-3 years experience of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management etc)
MUST HAVE 3: Excellent communication skills and computer skills.
Candidates will have to complete a questionnaire and narrative.