Job Title: Pharmacovigilance Associate
Location: Ciudad De Mexico, Mexico
Company: Teva Pharmaceuticals
Job ID: 59479
Date: Nov 26, 2024
About Teva Pharmaceuticals
Teva’s mission is to make good health more affordable and accessible globally, helping millions of people live healthier lives. As the world’s leading manufacturer of generic medicines, Teva produces many essential products on the World Health Organization’s Essential Medicines List. Today, 200 million people rely on Teva medicines daily. Join us to be part of our mission to make a meaningful difference for people worldwide.
The Opportunity
As a Pharmacovigilance Associate, you will be a core member of the safety team responsible for performing pharmacovigilance activities within the North America PV unit. This includes collaborating with Drug Safety Specialists, Pharmacovigilance Safety Specialists, and Managers to ensure the accurate receipt, review, and processing of adverse event information for both pre and post-marketing products.
Key Responsibilities
Adverse Event Intake & Registration: Extract, upload, and intake adverse event information, including XMLs.
Case Management: Register adverse event cases by entering searchable data and ensuring the reportability to regulatory authorities (FDA/Health Canada) as required.
Follow-Up & Data Collection: Contact reporters to gather additional information, perform follow-ups with healthcare professionals and consumers, and ensure timely reporting.
Regulatory Compliance: Send adverse event information to license partners as per pharmacovigilance agreements.
Audit Support: Participate in pharmacovigilance audits and inspections.
CAPA Management: Draft and finalize Corrective and Preventative Actions (CAPAs) for late submissions or non-compliance with internal processes.
SOP/WI Updates: Assist in revising Standard Operating Procedures (SOPs) and Work Instructions (WIs) to comply with new regulations or improve efficiency.
Training: Train new hires in pharmacovigilance systems and processes.
Reconciliation: Perform reconciliations of adverse event reports with identified partners and source documents from internal departments.
Documentation: Accurately draft and archive pharmacovigilance agendas, meeting minutes, and related documents.
Qualifications & Experience
Education: Bachelor of Science in Physics, Chemistry, Biology, Biochemistry, Microbiology, Physiology, Anatomy, Pharmacology, or related field.
Experience:
1-3 years of experience in the pharmaceutical industry or Clinical Research Organizations (CRO), with at least 1 year in Pharmacovigilance.
Proficiency in Microsoft Office (Word, Excel, PowerPoint, Adobe Acrobat).
Experience with PhV IT systems (Arisg, Argus, Cognos) is an added advantage.
Skills:
Teamwork & Communication: Demonstrates good collaboration, critical thinking, and communication skills.
Attention to Detail: Ability to review and assess adverse event information accurately.
Problem-Solving: Strong problem-solving abilities in the context of pharmacovigilance.
Why Teva?
Global Impact: Contribute to the safety of medicines that impact 200 million lives worldwide.
Professional Growth: Develop expertise in pharmacovigilance while gaining hands-on experience with various systems and processes.
Inclusive Culture: Teva promotes diversity and inclusivity, fostering a collaborative work environment for all.
Teva Pharmaceuticals is an Equal Opportunity Employer, committed to diversity and inclusion. If you require accommodations during the recruitment process, please let us know, and we will ensure an accessible candidate experience.
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