Pharmacovigilance Executive Vacancies in Mumbai at Apotex

Apotex Inc. is a renowned Canadian-based global health company committed to producing high-quality, affordable medicines. With a workforce of nearly 7,200 employees globally, Apotex’s operations span manufacturing, R&D, and commercial activities. The company’s medicines are accessible in over 75 countries, focusing on generic, biosimilar, and specialty products.

Job Summary

We are excited to share that Apotex is hiring Pharmacovigilance Executives in Mumbai! In this role, you will prepare periodic safety update reports (PSURs/PBRERs) in compliance with drug safety regulations and ICH guidelines. You will utilize medical judgment to analyze and evaluate adverse reports, resolve causality assessment queries, and participate in global new product development (NPD) projects. Additionally, you will support Product Life Cycle Management (PLCM) activities.

Job Responsibilities

Primary Responsibilities

• Prepare periodic safety update reports (PSURs/PBRERs/PADERs) for regulatory submission.
• Maintain awareness of safety issues on Apotex products through ongoing monitoring and literature review.
• Prepare responses to complex safety information queries from internal customers (RA, QA, NPD project teams, etc.).
• Ensure compliance with all global business ethics, quality, safety, and HR policies.

Additional Responsibilities

• Develop and maintain Standard Operating Procedures (SOPs) and training documents.
• Track compliance of internal and external global partners involved in drug safety reporting.
• Maintain user-level knowledge of Oracle ARGUS and MedDRA terminology.
• Collaborate with team members to achieve outcomes aligned with Apotex’s values of Collaboration, Courage, Perseverance, and Passion.
• Contribute to process improvement strategies and maintain strong working relationships with external partners and international affiliates.

Qualifications

• Education: Pharm.D, M.Pharm, Nursing, or related Health Science discipline.
• Experience: Core PV experience of at least 2-3 years in the pharmaceutical industry. Preferred experience includes 1-2 years on periodic reviews of aggregate safety data.
• Skills:
  • Excellent analytical and problem-solving abilities.
  • Proficiency in oral and written English communication.
  • Knowledge of MedDRA, Oracle ARGUS, and online literature searching.
  • Strong organizational and interpersonal skills, with experience working in dynamic team environments.
  • Advanced knowledge of Microsoft Office applications: Excel, PowerPoint, Word.
  • Familiarity with local and international regulations and ICH guidelines on safety data management in clinical trials and post-approval settings.

Location

• City: Mumbai, Maharashtra, India
• Postal Code: 400083

How to Apply

To apply for the Pharmacovigilance Executive vacancies at Apotex in Mumbai, please visit the Apotex Careers page and submit your application by following the provided instructions.