Teva Pharmaceuticals is dedicated to improving access to affordable, high-quality medicines. With a presence in nearly 60 countries, our diverse team supports millions globally. Every day, at least 200 million people rely on Teva’s medicines, many of which are listed as essential by the World Health Organization. Join us in transforming healthcare with innovative and sustainable solutions.
Responsibilities in This Role
As a Pharmacovigilance Associate II, you will play a key role in the preparation of aggregate reports, ensuring compliance with safety and regulatory standards. Your daily tasks include:
- Generating and collecting required reports (line listings, summary tabulations) using pharmacovigilance databases and BI platforms.
- Supporting report preparation by providing data and authoring relevant sections.
- Ensuring accuracy of case information in the PV database and raising corrections as needed.
- Conducting case assessments to separate formulations, dosages, or indications before report generation.
- Performing quality control (QC) checks on generated data and authored sections.
- Acting as a topic lead for specific projects and mentoring junior staff.
- Drafting responses to regulatory and stakeholder queries.
- Maintaining training documents and working procedures under the team’s scope.
- Ensuring all tasks align with Teva’s procedural documents and regulatory standards.
Qualifications
To be successful in this role, you need the following qualifications:
- Educational Background:
- BDS, BAMS, BHMS, Pharm.D, or M.Pharm (specializations in Pharmacy Practice, Pharmacology, or Regulatory Affairs).
- Experience:
- 2-3 years in pharmacovigilance (experience in medical writing or case processing for clinical trials is preferred).
- Prior experience in preparing periodic reports is highly desirable.
Key Skills Required
- Strong understanding of pharmacovigilance databases and reporting standards.
- Excellent data analysis and problem-solving skills.
- Ability to collaborate with cross-functional teams effectively.
- Proficiency in medical writing and preparation of regulatory documents.
- Attention to detail, especially in performing QC tasks.
- Leadership qualities to coach and mentor junior staff
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