Drug Safety Associate

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Drug Safety Associate

work outline iconFresherrupess outline iconNot disclosed time outline iconFull Time

Zeyos Health, Pune

time outline iconPune, Maharashtra, India

Posted on 28-09-2023

923 Views

1 Vacancy

Description

  • Identify out of scope activities in conjunction with the MSS Functional Lead.
  • Determining the category of information received whether it is a Medical Inquiry, Product Quality Complaint (PQC), an adverse event (AE) associated with a PQC, or an AE alone, and handling it accordingly per the relevant SOPs and guidelines.
  • Reconciliation activities with all data sources providing safety information - Specialty Pharmacies, Business Partners and Internal Stakeholders to ensure compliance.
  • Manage and process adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines.
  • Accurately capture data of adverse event reports on the safety database in accordance with global and local regulatory requirements.
  • Perform post surveillance activities such as literature review and media monitoring

Category

Others

Preferred Education

MSc (Master of Science)MPharm (Master Of Pharmacy)BSc (Bachelor of Science)BPharm (Bachelor Of Pharmacy)

Key Skills

Communication SkillsProblem Solving SkillsDecision-MakingPositive AttitudeTeam working

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