Drug Safety Specialist Role at Parexel Apply Online Now
--Must See--

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

  • Manage local and global SDEAs and Pharmacovigilance Agreements (PVAs) across investigational, post-marketing, and marketed products, including medical devices and vaccines.

  • Review PV obligations in contracts for ICSR, PSUR, PBRER, RMP, signal detection, and more.

  • Maintain contract management databases and ensure accurate tracking of agreement status.

  • Support configuration changes in safety databases and generate business partner reports.

  • Ensure timely contract execution aligned with project timelines.

  • Perform quality checks and participate in audits or inspections.

  • Assist with mailbox reconciliation, document filing, and KPI monitoring.

  • 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

  • Understanding of ICSR, signal detection, PSUR/DSUR, and risk management

  • Familiarity with global PV regulations (FDA, EMA, ICH)

  • Knowledge of medical terminology and safety coding

  • Contract management or SDEA experience is highly preferred

  • Proficient in MS Office, web-based tools, and safety databases

  • Strong analytical and multitasking ability

APPLY ONLINE HERE

Keywords: Drug Safety Specialist, Pharmacovigilance, Safety Data Exchange Agreement, Life Sciences, Pharmacy, Drug Safety Specialist Role, Global Regulations

Shekhar
Shekhar Suman is the Co-founder of BioTecNika Info Labs Pvt. Ltd. He is an Entrepreneur, Writer, Public Speaker, and a Motivational Coach. In his career, he has mentored more than 100,000+ students toward success in the Biopharma Industry. He heads the BioTecNika Group, which comprises BioTecNika.com, BioTecNika.org, and Rasayanika.com. An avid reader and listener who is passionate about BioSciences. Today Biotecnika is India's largest Biotech Career portal, with over 5 Million subscribers from academia & Industry. It's ranked among the top 50 websites worldwide in the Biology category.

LEAVE A REPLY

Please enter your comment!
Please enter your name here