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Pharmacovigilance Associate Ii

2-3 years
Not Disclosed
10 Feb. 6, 2025
Job Description
Job Type: Full Time Education: BDS/BAMS/BHMS/Pharm.D/M.Pharm 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

Pharmacovigilance Associate II

📍 Location: Bangalore, India, 560064
💼 Job Id: 60345
🕒 Date Posted: Jan 21, 2025

Company Overview:

Teva Pharmaceuticals is committed to improving global health by making affordable and accessible medicines. As the world’s leading manufacturer of generic medicines, Teva’s products reach at least 200 million people every day. With a diverse, mission-driven workforce spanning nearly 60 countries, Teva continues to innovate and make a difference in patients' lives worldwide.

Job Overview:

As a Pharmacovigilance Associate II at Teva, you will play a key role in supporting the aggregate reports preparation process. You will generate, collect, and ensure the accuracy of data to aid in report preparation, along with authoring relevant sections. You will also support quality control (QC) activities and mentor junior staff.

Key Responsibilities:

  • Report Generation: Generate line listings and summary tabulations from the pharmacovigilance database and business intelligence (BI) platforms.
  • Data Collection & Assimilation: Collect and organize data to assist report writers and author relevant sections of reports.
  • Data Quality Control: Ensure data completeness and accuracy within the pharmacovigilance database, raising and following up on correction requests as needed.
  • Case Assessment: Perform case separation as required prior to report generation.
  • Quality Assurance: Review and perform QC of data generation, collection, and authoring for assigned reports.
  • Team Leadership: Act as a topic lead for selected processes/projects and mentor junior staff.
  • Regulatory Support: Draft responses to queries from stakeholders and regulatory agencies.
  • Documentation: Maintain and author training documents and working procedures.
  • Collaboration: Work collaboratively with peers, writers, and other teams across Teva.

Qualifications & Experience:

  • Education: University degree (BDS, BAMS, BHMS, Pharm.D, M.Pharm in Pharmacy Practice/Pharmacology/Regulatory Affairs).
  • Experience: 2-3 years in pharmacovigilance (medical writing, ICSR/case processing, or clinical trials). Experience in preparing periodic reports is desirable.
  • Skills: Strong attention to detail, excellent communication, and the ability to work collaboratively within cross-functional teams.

Equal Employment Opportunity:

Teva is committed to providing equal employment opportunities to all qualified individuals regardless of their background, identity, or any legally recognized status. Teva fosters a diverse and inclusive work environment.