Senior Executive/Manager 2 - Global Pharmacovigilance

Responsibilities

• Evaluate incoming communications for potential adverse event reports via various intake methods including phone, fax, mail, and social media.
• Medically evaluate and process adverse event reports daily to determine seriousness and facilitate expedited reporting to the FDA and Health Canada.
• Report cases to the appropriate regulatory authorities within required timeframes.
• Process daily queries and provide responses within the same business day.
• Manage literature cases and maintain necessary report spreadsheets.
• Perform trending for adverse event reporting by preparing quarterly reports and Annual Summary reports for products marketed in Canada.
• Support internal audits and external inspections.
• Conduct monthly Health Canada adverse event searches in the vigilance database.
• Perform reconciliations for Product Quality complaints and reports involving partners.

Requirements

• BDS, MDS, M.Pharma in a healthcare or science discipline, or applicable healthcare certifications (e.g., RN, Pharmacist).
• 5+ years of experience in pharmacovigilance or a related field.
• Working knowledge of FDA and Health Canada guidelines for post-marketing drug and medical device safety surveillance.
• Proficiency in medical terminology and MedDRA.
• Experience with drug safety databases such as Argus or Wilke.
• Strong proficiency in MS Office (Word, Excel, PowerPoint).
• Ability to analyze and interpret scientific and technical journals.
• Ability to multi-task and manage workloads under pressure.

About the Company

Sun Pharmaceutical Industries Ltd is a global pharmaceutical leader committed to fostering an environment of continuous growth and collaboration. We empower our employees to take charge of their professional journeys while working together to make a lasting impact on global healthcare.