Safety Specialist

3 days ago


Remote, India beBeePharmacovigilance Full time ₹ 15,00,000 - ₹ 28,00,000
About the Role

This position is responsible for reviewing and processing safety events, analyzing abstracts and full articles, generating data listings from the safety database, and completing adverse event follow-ups.

Key Responsibilities
  • Review and process safety events according to project-specific procedures.
  • Analyze abstracts and full articles to identify safety information for marketed and investigational products.
  • Generate and ensure accuracy of data listings from the safety database.
  • Complete adverse event follow-ups via writing or phone, adhering to client requirements.
  • Maintain safety tracking systems for accuracy and quality, supporting development of the Safety Management Plan.
  • Assist in creating post-marketing safety documents, such as PSMF, RMP, and PBRER.
  • Liaise with investigational sites, reporters, and sponsors regarding safety issues.
  • Support generation of aggregated safety reports, including Development Safety Update Reports and IND Annual Reports.
  • Assist with interim data analysis for DMC reviews and maintain quality control in the safety database.
  • Contribute to signal detection and risk management activities alongside the Safety Scientist.
  • Support audits and inspections for assigned projects and respond to medical information inquiries.


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