Drug Safety Specialist Jobs at Parexel | Apply Online Now
Parexel is hiring a Drug Safety Specialist – SDEA to manage and maintain Safety Data Exchange Agreements (SDEAs) and pharmacovigilance obligations for global drug safety. If you have a Bachelor’s or Master’s in Life Sciences or Pharmacy, and 2–3 years of experience in pharmacovigilance or clinical research, this full-time opportunity offers dynamic exposure to regulatory frameworks and safety data coordination. Join Parexel’s expert medical sciences team to help ensure global safety compliance.
About Parexel
Founded in 1982, Parexel is a leading global biopharmaceutical services organization that provides a broad range of expertise and capabilities to help clients expedite time-to-market. With a focus on innovation and collaboration, Parexel strives to bring life-changing treatments to patients worldwide.
Job Details:
Job Title: Safety Data Exchange Agreement (SDEA) Drug Safety Specialist
Job ID: R0000033067
Category: Medical Sciences
About this Role
The SDEA Pharmacovigilance (PV) Specialist is responsible for managing Safety Data Exchange Agreements between the company and its partners in the contract management database, ensuring compliance with global pharmacovigilance regulations, and facilitating the efficient exchange of safety information.
Key Responsibilities
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Manage local and global SDEAs and Pharmacovigilance Agreements (PVAs) across investigational, post-marketing, and marketed products, including medical devices and vaccines.
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Review PV obligations in contracts for ICSR, PSUR, PBRER, RMP, signal detection, and more.
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Maintain contract management databases and ensure accurate tracking of agreement status.
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Support configuration changes in safety databases and generate business partner reports.
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Ensure timely contract execution aligned with project timelines.
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Perform quality checks and participate in audits or inspections.
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Assist with mailbox reconciliation, document filing, and KPI monitoring.
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Provide training on SDEA processes to internal teams.
Qualifications
- Bachelor’s degree in Life Sciences, or related field
- 2–3 years of relevant experience in pharmacovigilance, drug safety, or clinical research
Desired Skills
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Understanding of ICSR, signal detection, PSUR/DSUR, and risk management
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Familiarity with global PV regulations (FDA, EMA, ICH)
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Knowledge of medical terminology and safety coding
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Contract management or SDEA experience is highly preferred
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Proficient in MS Office, web-based tools, and safety databases
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Strong analytical and multitasking ability
Keywords: Drug Safety Specialist, Pharmacovigilance, Safety Data Exchange Agreement, Life Sciences, Pharmacy, Drug Safety Specialist Role, Global Regulations
