Drug Safety Specialist – Pharmacovigilance (SDEA Specialist)
Location: Remote
Job Summary:
Parexel is hiring a Drug Safety Specialist – Pharmacovigilance to manage global Safety Data Exchange Agreements (SDEA) and ensure compliance with international pharmacovigilance regulations. This remote position involves coordinating safety information exchange, managing safety databases, and supporting global pharmacovigilance processes for clinical and marketed products, including vaccines and medical devices. An excellent opportunity to contribute to worldwide drug safety and PV operations.
Key Responsibilities:
Manage Global and Local SDEAs, PV clauses, and Vigilance Agreements for investigational and marketed products
Review and assess PV obligations related to ICSR processing, PSURs/PBRERs, RMPs, signal detection, and literature screening
Update and configure safety databases as per PV requirements
Generate Business Partner reports and maintain the Contract Management Database
Track agreements, expirations, and amendments; ensure proper documentation
Provide SDEA process guidance to stakeholders and conduct training sessions
Perform quality checks on data entries and monitor KPIs and metrics
Support periodic aggregate report teams in PSURs/DSURs preparation
Stay updated with global PV regulations and best practices
Assist during audits and inspections related to safety data processes
Required Skills & Qualifications:
Bachelor’s degree in Life Sciences, Pharmacy, or related field (Advanced degree preferred)
2-3 years of experience in pharmacovigilance or clinical research
Experience in SDEA/PVA management and safety database handling
Strong knowledge of ICH, EMA, FDA PV guidelines
Understanding of ICSR processing, aggregate reporting, signal detection, and RMPs
Familiarity with master service agreements and PV terminologies
Proficient in medical terminology and adverse event coding
IT proficiency with MS Office Suite and web-based applications
Desired Skills:
Analytical skills for safety data evaluation
Independent decision-making abilities
Strong teamwork and client-focused approach
Ability to prioritize multiple tasks with attention to detail
Exposure to automation or AI tools in pharmacovigilance is a plus
Perks & Benefits:
Remote work flexibility
Exposure to global pharmacovigilance operations
Training and career development programs
Participation in audits and regulatory inspections
Opportunity to work with global biopharma leaders
Company Description:
Parexel is a globally recognized Clinical Research Organization (CRO) dedicated to improving patient health through clinical trials, drug development, and pharmacovigilance services. With a focus on innovation and regulatory compliance, Parexel empowers healthcare organizations worldwide.
Work Mode:
Remote
Call to Action:
Ready to advance your pharmacovigilance career? Apply now for the Drug Safety Specialist role at Parexel and play a vital part in ensuring global drug safety compliance.
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