Pharmacovigilance Scientist

About the role

ProPharma is seeking a dedicated Pharmacovigilance (PV) Safety Scientist to join its Benefit‑Risk team. The role supports key pharmacovigilance activities, delivering high‑quality safety and regulatory outputs while collaborating with senior PV scientists, management, and cross‑functional stakeholders.

Key responsibilities

• Author aggregate safety reports such as PSURs, PBRERs, PADERs, Annual Reports and ACODSURs.
• Prepare and maintain Risk Management Plans (RMPs).
• Author and contribute to Signal Management Reports.
• Conduct literature searches, screening, validity checks and duplicate checks using appropriate tools.
• Extract and validate safety data (e.g., RSI, sales data, prior reports, signals).
• Generate and review line listings from safety databases.
• Reconcile and maintain process trackers.
• Support high‑priority and ad‑hoc pharmacovigilance activities.
• Ensure deliverables comply with global regulatory requirements and timelines.
• Participate in internal and external audits/inspections as a Subject Matter Expert.
• Contribute to SOP/WI development, deviations, and CAPAs.

Required profile

• Bachelor’s or Master’s degree in Pharmacy, Nursing, Life Sciences or a related healthcare/scientific field (equivalent experience may be considered).
• Minimum 2 + years of experience in Pharmacovigilance.

Required skills

• Solid understanding of global PV regulations (ICH‑GCP, FDA, EMA, etc.).
• Proficiency in MS Office (Word, Excel, PowerPoint) and web‑based applications.

What we offer

• Remote work with periodic office attendance in Hyderabad.
• Opportunity to work within a global, matrixed environment on high‑profile drug and device programs.