Job Title: Drug Safety Specialist – Pharmacovigilance (SDEA/PVA)
Job Summary:
Parexel is hiring a detail-oriented Drug Safety Specialist focused on the management of Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs) for investigational and marketed products. This role requires 2–3 years of pharmacovigilance experience and a deep understanding of global PV regulations and contract terms. You will ensure compliance with ICH, EMA, FDA standards and provide expert guidance across safety data exchange processes to support the drug safety lifecycle.
Key Responsibilities:
Manage global/local SDEAs, PVAs, vigilance agreements, and clinical supply agreements.
Review contractual PV obligations on ICSRs, PSURs, PBRERs, RMPs, signal reports, and literature.
Maintain and update safety database configurations and contract management systems.
Generate business partner contact reports and ensure up-to-date implementation.
Track all agreements, expiration timelines, and updates in global trackers.
Ensure timely execution and tracking of PVAs with strict SOP adherence.
Support preparation of aggregate safety reports (e.g., DSURs, PSURs).
Conduct quality checks and monitor key performance indicators (KPIs).
Stay up-to-date with evolving pharmacovigilance regulations and industry trends.
Participate in audits/inspections related to SDEA operations.
Required Skills & Qualifications:
Bachelor's degree in Life Sciences, Pharmacy, or a related field; advanced degree preferred.
2–3 years’ experience in pharmacovigilance, SDEA/PVA management, or clinical research.
Strong knowledge of global PV regulations (ICH, EMA, FDA).
Expertise in handling ICSRs, aggregate safety reports, signal detection, labeling, and risk management.
Understanding of safety database systems and medical terminology.
Familiarity with master service agreements and PV clauses.
Proficiency in Microsoft Office Suite and web-based applications.
Knowledge of automation and AI in PV is a plus.
Perks & Benefits:
Competitive compensation package
Global career development opportunities
Collaborative and inclusive team culture
Exposure to global drug safety and PV operations
Hybrid or remote work flexibility
Company Description:
Parexel is a globally respected CRO and life sciences consultancy, offering advanced drug development, regulatory compliance, and clinical research services. With a strong presence in global pharmacovigilance, Parexel is trusted by top pharmaceutical companies to manage critical safety operations.
Work Mode: Hybrid or Remote (based on location and role alignment)
Call to Action:
Are you passionate about drug safety and regulatory excellence? Apply now to join Parexel as a Drug Safety Specialist and contribute to advancing global health through effective pharmacovigilance compliance.
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