Job Summary
Parexel is hiring a skilled Drug Safety Specialist (SDEA Pharmacovigilance Specialist) in Hyderabad, India. The role focuses on managing Safety Data Exchange Agreements (SDEA) and Pharmacovigilance Agreements (PVA) to ensure regulatory compliance across investigational and marketed products. This position plays a crucial role in ensuring efficient exchange of safety data, supporting clinical safety activities, and aligning global pharmacovigilance standards.
Key Responsibilities
Manage Global and Local SDEAs and PVAs for clinical trials and marketed products.
Review PV obligations in various reports including ICSRs, PSURs, PBRERs, RMPs, and safety listings.
Update and configure safety database management requests.
Build and maintain Contract Management database reports for operational functions.
Track all SDEAs, PVAs, amendments, and expiration dates in comprehensive trackers.
Provide SDEA-related guidance to internal and external stakeholders.
Ensure compliance with SOPs, regulatory guidelines, and project timelines.
Support periodic aggregate report preparation including PSURs/DSURs.
Perform mailbox management, reconciliations, and data quality checks.
Deliver training on SDEA processes to relevant staff.
Monitor key performance indicators and support audits/inspections.
Required Skills & Qualifications
Bachelor’s in Life Sciences, Pharmacy, or related field (Master's preferred).
2–3 years’ experience in pharmacovigilance or clinical research.
Strong knowledge of global PV regulations (ICH, EMA, FDA).
Experience in ICSRs, Aggregate safety reports, Signal detection, Risk management.
Familiarity with safety databases and contract (SDEA/PVA) management.
Good understanding of medical terminology and adverse event coding.
Excellent analytical, data evaluation, and problem-solving skills.
Proficient with MS Office Suite (Word, Excel, PowerPoint).
Experience in automation or AI is an advantage.
Perks & Benefits
Opportunity to work with a global leader in clinical research and pharmacovigilance.
Collaborative and client-focused work culture.
Exposure to international regulatory standards and best practices.
Professional growth and development opportunities.
Company Description
Parexel is a global leader in clinical research, drug development, and regulatory consulting, dedicated to improving patient health worldwide. With a strong presence in India, Parexel offers innovative solutions for drug safety, regulatory compliance, and clinical trials.
Work Mode
On-site | Hyderabad, India
Call to Action
Ready to advance your pharmacovigilance career? Apply now to become part of Parexel’s mission to improve global health through excellence in drug safety and clinical research.
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