Drug Safety Associate - Clinical Safety And Pharmacovigilance

Department Icon Others
85+ Applicants
Posted: 1 hour ago
0-2 years
Noida, India
work from office

Posted: 1 hour ago
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Applicants: 85+
Job Description
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Job Description

Key Responsibilities:
  • Record and review adverse reactions in the safety database for post marketing and clinical trial reports in accordance with applicable regulatory standards, with high accuracy and quality.
  • Assessment and review of literature abstracts and full-text articles.
  • Communicate with required stakeholders, as necessary, to carry out the operational responsibilities.
  • Carry out necessary administrative duties required for the job.
  • Support effective functioning of PV projects (including but not limited to case processing,
  • Literature Monitoring, Aggregate Reporting, Medical Writing, Signal Detection and
  • Management, Medical Information and Risk Management etc.) in compliance with agreements and applicable regulations and guidelines.
  • Have ownership of assigned projects and tasks and ensure adherence to timelines and quality.
  • Management of quality, compliance and documentation across PV projects.
  • Other responsibilities as assigned by the Management.
Education & Experience:
  • B.Pharm / M.Pharm / BDS or equivalent qualification from a reputed institute recognized by Pharmacy Council of India
  • 0-1 years of experience in drug safety/pharmacovigilance

Skills

Risk ManagementCompliancePharmacovigilance

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About Company

Soterius is a specialized pharmacovigilance and medical writing company providing drug safety and regulatory services to the pharmaceutical and biotechnology industries.

Important dates & deadlines?

Application Deadline

08 Dec 26, 08:30 PM IST

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Drug Safety Associate - Clinical Safety And Pharmacovigilance

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