Drug Safety Specialist Job – at Parexel, Apply Now!
Are you ready to take your pharmacovigilance career to the next level? Parexel is hiring a highly skilled Drug Safety Specialist to manage Safety Data Exchange Agreements (SDEAs) in a dynamic global environment. This role plays a critical part in ensuring compliance with pharmacovigilance regulations, managing PV agreements, supporting audits, and providing essential guidance on drug safety obligations. Ideal for professionals with 2–3 years of experience, this is your chance to join a global leader in clinical research and medical sciences.
About Company:
Parexel is a leading global consulting organization specializing in the life sciences industry. With a focus on providing innovative solutions for drug development and commercialization, Parexel helps clients bring new therapies to market efficiently and effectively.
Job Title: Safety Data Exchange Agreement (SDEA) Drug Safety Specialist
Job ID: R0000033067
Category: Medical Sciences
Job Summary:
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 efficient exchange of safety information, coordinating with various stakeholders, manage the lifecycle of SDEAs/PVAs for business relationships ensuring to meet the standard
process and applicable regulatory requirements. Responsible to assess contractual information related to PV obligations on different type of reports like individual case safety reports, aggregate reports, signal reports, literature screening and other PV related aspects.Key Responsibilities:
- Management of Global and Local SDEAs
- Review and assessment of PV obligations from contracts
- Management of Safety database related configuration requests and updates
- Build and manage reports (Business Partner lists) periodically from the Contract management database
- Maintain a database of all agreements and track their status
- Provide guidance on SDEA-related issues to stakeholders
- Ensure timely execution of SDEAs
- Conduct training sessions on SDEA processes and requirements for relevant staff
- Monitor Key Performance Indicators (KPIs)
- Stay current with global pharmacovigilance regulations
- Participate in audits and inspections
Qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field
- 2-3 years of experience in pharmacovigilance, clinical research, or a related field
- Advanced degree preferred
Knowledge and Experience:
- Related experience in drug safety/pharmacovigilance and contract management is desirable
- Strong knowledge of global pharmacovigilance regulations
- Understanding of medical terminology and adverse event coding
- Experience in automation/artificial intelligence would be an asset
Desired Skills:
- Sound knowledge of drug safety and data analysis
- Client-focused approach to work
- Ability to manage multiple tasks with attention to detail
- Computer proficiency and IT skills
Keywords: Drug Safety Specialist, Parexel, Pharmacovigilance, SDEA, Drug Safety, Life Sciences
