Operation Specialist 2
Buenos Aires, Argentina
hace 1 día

Job overview :

Provides data gathering, entry, and reporting services on behalf of contracted customers, including both clinical trial and marketed product safety activities.

  • Triages, tracks, and processes safety data; assesses safety data for report-ability to the client safety department or relevant regulatory bodies;
  • maintains communication (phone, fax, email) with investigative sites or marketed product reporters to obtain accurate data regarding safety events;
  • and contributes to lifecycle safety deliverables

    Responsibilities :

  • Analyzing in-process quality checks, reporting of results, tracking quality findings, metrics against, defined KPIs
  • Analyzing quality deviations, identifying root causes, adjudicating ICSR corrections with corresponding issuance of CAPA, as appropriate, to evaluate CAPA effectiveness
  • Driving continuous process improvement for Case Management by partnering with all entities, Country Safety Leads, License Partners, and vendors
  • overseeing CAPA management for Case Management
  • managing vendor quality activities, identifies opportunities for improvement; managing Case Management compliance
  • overseeing the in-process workflow of all ICSRs and implementing strategies to prevent late ICSR reports
  • serving as a SME during internal / partner audits and Health Authority inspections in this role
  • Requirements :

  • Bachelor's Degree Minimum of three years of experience in international pharmacovigilance area; certified degree in a Health Science area (Pharmacist, PharmD, Registered Nurse) or a minimum of 5 years of experience in ICSR management.
  • Working knowledge of global pharmacovigilance regulations strong knowledge of medical terminology excellent communication
  • kills computer literacy, use of MS Office (e.g. Word, Excel, ect.)
  • must have excellent oral and written skills in English
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