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Pharmacovigilance Associate Ii

2-3 years
Not Disclosed
10 Feb. 12, 2025
Job Description
Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Pharmacovigilance Associate II
Location: Bangalore, India, 560064
Company: Teva Pharmaceuticals
Job ID: 60345
Date: January 21, 2025

About Teva Pharmaceuticals:

Teva Pharmaceuticals is a global leader in generic medicines with a mission to make good health more affordable and accessible. With products reaching over 200 million people every day, Teva is committed to improving lives worldwide. It is a proud producer of many products on the World Health Organization’s Essential Medicines List and continues to innovate to make a difference in healthcare.

The Opportunity:

Teva is looking for a Pharmacovigilance Associate II to support the preparation of aggregate reports and provide data support to writers. This role involves generating reports, collecting and assimilating data, and providing quality control to ensure timely and accurate report preparation. The role also involves mentoring junior staff and supporting responses to regulatory agency queries.

Key Responsibilities:

  • Report Generation: Generate required reports (line listings, summary tabulations) from pharmacovigilance (PV) databases and BI platforms for assigned reports.
  • Data Collection & Support: Collect and assimilate data to support the writers in report preparation and author relevant sections of assigned reports.
  • Case Management: Ensure cases within the PV database are complete and accurate by raising correction requests to relevant teams and following up until resolution.
  • Quality Control (QC): Review and perform QC of the data generation, collection, and authoring process for assigned reports.
  • Team Leadership: Act as a topic lead for selected parts of the process and mentor junior staff within the team.
  • Regulatory & Internal Communication: Draft responses to queries from stakeholders and regulatory agencies as required.
  • Documentation & Procedures: Author and maintain training documents and working procedures related to pharmacovigilance activities.
  • Collaboration: Work collaboratively with peers, writers, and other functions within the organization to ensure smooth and efficient workflow.

Qualifications & Experience:

  • Education: University degree (BDS, BAMS, BHMS, Pharm.D, M.Pharm in Pharmacy Practice, Pharmacology, or Regulatory Affairs).
  • Experience: 2-3 years of experience in Pharmacovigilance, including medical writing and/or ICSR/case processing in clinical trials. Previous experience with periodic report preparation is a plus.

Teva’s Equal Employment Opportunity Commitment:

Teva Pharmaceuticals is an equal opportunity employer, committed to providing employment opportunities without discrimination. The company fosters a diverse and inclusive workplace for all employees, ensuring that all candidates have the necessary accommodations throughout the recruitment process. All accommodation information will be kept confidential.

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For more details, visit Teva Pharmaceuticals Careers.