Parexel Hiring Drug Safety Specialist role in Pharmacovigilance (SDEA)

Drug Safety Specialist Opportunity for Life Sciences & Pharmacy Graduates – Apply Now

Hiring for Drug Safety Specialist role in Pharmacovigilance (SDEA) – Life Sciences or Pharmacy graduates with 2–3 years’ experience. Location Hyderabad

Career Opportunity: Drug Safety Specialist – Pharmacovigilance (SDEA Specialist)

Are you a Life Sciences or Pharmacy graduate with 2–3 years of experience in pharmacovigilance or clinical research? A fantastic opportunity awaits you as a Drug Safety Specialist (SDEA) in the Medical Sciences domain. This role is ideal for those with strong knowledge in global PV regulations, ICSRs, PSURs, and contract management.

Key Responsibilities

• Manage Global and Local Safety Data Exchange Agreements (SDEAs) and PV clauses.
• Review and assess pharmacovigilance obligations from multiple contract types including ICSRs, PSURs, PBRERs, RMPs, and more.
• Track, store, and maintain all executed PVAs in a central tracker and filing system.
• Coordinate updates and configuration requests within the safety database.
• Provide periodic business partner reports from the contract database.
• Offer guidance and training to internal teams on SDEA processes.
• Perform Quality Checks, ensure SOP adherence, and support audit readiness.
• Monitor KPIs and ensure process compliance with ICH, EMA, and FDA guidelines.

Required Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, or related field (Master’s degree preferred).
• 2–3 years’ experience in Pharmacovigilance or Clinical Research.
• Experience in contract management (SDEA/PVA), PV processes, and regulatory documentation.

Preferred Skills and Competencies

• Solid understanding of drug safety terminologies and processes.
• Familiarity with ICSR, Aggregate reports, Signal detection, Risk management, and AI-based automation tools.
• Strong interpersonal, analytical, and organizational skills.
• Expertise in Microsoft Office and web-based systems.

How to Apply

Interested candidates can apply via the official job portal:
👉 Apply Here

Summary Table

Tagged as: API Manufacturing, Good Clinical Practice (GCP), Pharmaceutical Jobs, Pharmacology