PV Team Member

2 days ago


Noida, Uttar Pradesh, India beBeepharmacovigilance Full time ₹ 1,04,000 - ₹ 1,30,878
Pharmacovigilance Specialist Job Description

We are seeking a highly skilled Pharmacovigilance Specialist to join our team. As a PV Specialist, you will play a critical role in our pharmacovigilance efforts, handling key tasks such as data entry, initial assessments, expedited reporting evaluation, and case completion.

Your primary responsibilities will include:

  • Data Entry: Accurately input data into the PV database to ensure compliance with regulatory requirements.
  • Initial Assessment: Perform initial assessments of Individual Case Safety Reports (ICSRs) to identify potential safety issues.
  • Expedited Reporting Evaluation: Evaluate the necessity for expedited reporting to Health Authorities or client partners, adhering to reporting timelines.
  • Reporting Preparation: Prepare standard reporting forms, including 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 to maintain data integrity.
  • Quality Check: Conduct quality checks on ICSRs to detect any discrepancies or errors.
  • Search/Retrieval: Perform the ICSR search and retrieval process from the EVWEB database and assess cases from both company and non-company sources.
  • Case Management: Allocate and manage cases effectively within the team.
Requirements

To be successful in this role, you must possess the following skills and qualifications:

  • Experience: Minimum 1 year of case processing experience.
  • Software Knowledge: Proficient in ARGUS and ARISG.
  • Qualification: B.Pharm, BDS, Pharm D, or M.Pharm degree.
  • Communication Skills: Excellent verbal and written communication skills.
  • Work Environment: Willingness to work from the office in Noida.

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