PV Team Member

5 days ago

Noida, Uttar Pradesh, India beBeePharmacovigilance Full time
Job Overview">

As a PV Specialist, you will be an integral part of our pharmacovigilance efforts, handling key responsibilities such as data entry, initial assessments, and expedited reporting evaluation.

  • Data Entry: Accurately input data into the PV database.
  • Initial Assessment: Perform initial assessments of Individual Case Safety Reports (ICSRs), as applicable.
  • Expedited Reporting Evaluation: Evaluate the necessity for expedited reporting to health authorities or client partners, including adherence to reporting timelines.
  • Reporting Preparation: Prepare standard reporting forms (e.g., CIOMS I, MedWatch Forms, and XML for submission).
  • Follow-Up Requests: Prepare and send follow-up requests to obtain additional information as necessary.
  • ICSR Submission: Submit ICSRs to health authorities and client partners, ensuring compliance with regulatory requirements.
  • Case Completion: Ensure thorough documentation and completion of cases.
  • Quality Check: Conduct quality checks on ICSRs to maintain data integrity.
  • Search/Retrieval: Perform the ICSR search and retrieval process from the EVWEB database and assess cases from both company and non-company sources.

Key Responsibilities:

  1. Experience: Minimum 1 year of case processing experience.
  2. Software Knowledge: Proficient in ARGUS and ARISG.
  3. Qualification: B.Pharm, BDS, Pharm D, or M.Pharm.
  4. Communication Skills: Excellent verbal and written communication skills.
  5. Work Environment: Willingness to work from the office in Noida.
What We Offer
  • Professional Growth Opportunities.
  • A Collaborative Work Environment.
  • Opportunities for Training and Development.

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