Qualified Person – Pharmacovigilance Officer

About the role

The Qualified Person for Pharmacovigilance Officer will lead the drug safety function, overseeing the collection, evaluation, and reporting of adverse reaction data. This role ensures compliance with local and global pharmacovigilance regulations and coordinates with internal teams and external partners.

Key responsibilities

• Establish and maintain a single‑point system for collecting all suspected adverse reaction reports.
• Collect, evaluate, process, and submit Individual Case Safety Reports (ICSRs).
• Prepare and submit Periodic Safety Update Reports (PSURs) as required.
• Manage Risk Management Plans (RMPs) and Safety Data Exchange Agreements (SDEAs).
• Implement and maintain the Drug Safety System Database and master files, including data reconciliation with third parties.
• Conduct literature searches and respond to health authority safety queries.
• Contribute to Annual Product Quality Reviews and train employees on drug safety procedures.
• Ensure compliance with jurisdiction‑specific drug safety legislation and maintain consistent processes.
• Build and manage relationships with business partners, Cipla Global, and regulatory authorities.
• Hire, train, and manage the drug safety team, set objectives, and oversee performance.