Drug Safety Specialist

4 weeks ago


Pune, India The Hird Full time

  • Role – Drug Safety Physician.
  • Designation – Sr. Executive.
  • Location – Pune.
  • Qualification – MBBS/MD (Pharmacology).
  • Experience – 2 to 7 Years (ICSR)
  • Mode - Work from Office. (Kolkata)
  • Notice Period – Immediate joiners preferred.
  • CTC- Upto 25 LPA


Position Purpose: To Analyze, Review and Interpret Safety data.

Primary Responsibilities:


  • To Perform medical review of cases according to Wipro and client specific SOPs and conventions and guidelines in safety database.
  • Provides technical and medical expertise in medical assessments of causality of cases as necessary, including the assessment of quality within the process.
  • Perform quality review of completed or locked cases in safety database as required.
  • Writing of medical assessment comment in safety database
  • Identify process improvement opportunities and drives changes.
  • Contribution to safety and Pharmacovigilance training programs, development of Standard Operating Procedures and Other guidance documents.
  • Demonstrate Knowledge and ensure compliance with current and applicable global Pharmacovigilance regulations and guidelines.
  • Review the Adverse Events case Narrative, coding, Product/Indication, labelling in accordance with the respective reference safety documents, causality and medical history for medical completeness, accuracy and overall medical content.
  • To Review and Provide PV Therapeutic area input for development of protocols, IBs, SAPs documents, if required.
  • Contribute to solving reconciliations medical coding issues or discrepancies.
  • Identifies, communicates, and effectively manages potential safety issues.
  • Perform corrections, route cause and corrective & presentive actions if required
  • Perform other duties as assigned to support PV activities.




Additional Responsibilities:



  • Document and track all observations and recommendations in quality feedback tracking tool.
  • Provide appropriate feedback to the Team as and when needed.
  • Support revision/creation of workflow/process documents to optimize and/or improve quality and compliance.
  • Participate in inspections and audits by providing the requested information.
  • Promotion of awareness of procedural and quality requirements within the team.
  • Assistance in preparation or implementation of corrective/preventative actions relating to case processing.



Technical Competencies:



  • Knowledge of applicable regulations and guidelines for Pharmacovigilance.
  • Excellent understanding of medical terminology and familiarity with principles of clinical assessment of adverse events in the context of an international pharmaceutical industry.
  • Ability to independently resolve routine problems related to core case processing and surface issues constructively.
  • Demonstrated computer literacy, particularly in the use and management of relational databases.
  • Ability to manage one’s own productivity, time management, quality, and compliance in order to achieve acceptable results within given timelines.
  • Ability to achieve personal objectives while meeting departmental standards of performance.
  • Ability to work under supervision in a matrix organization.
  • Ensure training and understanding on case processing SOPs/guidelines/tools.
  • Prioritize cases as appropriate or as directed by Client.
  • Excellent oral and written communication skills with fluency in spoken and written English.




Qualification: MBBS or MBBS/MD degree from recognized Indian Medical College or Foreign Medical Graduates Exam (FMGE) Certified


Work Experience: 2 years of experience as Medical Reviewer or minimal 1 year of experience in aggregate analysis.



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