Parexel is a leading global clinical research organization (CRO) committed to improving world health through innovative drug development solutions. With over 16,000 employees across 100+ countries, Parexel offers comprehensive services in clinical trials, regulatory consulting, pharmacovigilance, and market access.
At Parexel, every role contributes to advancing therapies that benefit patients worldwide. Join a team driven by empathy, innovation, and a passion for making a difference in healthcare.
1. Medical Writer I
Job ID: R0000032114 | Location: Remote (Mohali/Hyderabad)
Job Description
- Prepare, update, and manage Periodic Safety Reports (PSURs, PBRERs, DSURs, PADERs, RMPs, INDARs, etc.)
- Conduct literature reviews for epidemiology and safety data.
- Generate line listings, perform regulatory submissions, and ensure compliance.
- Draft narratives for Clinical Study Reports (CSRs) and health authority responses.
- Schedule meetings, draft agendas/minutes, and track action items.
Experience & Skills Required
- Strong knowledge of pharmacovigilance regulations (ICH, FDA, EMA).
- Experience in medical writing for aggregate safety reports.
- Ability to perform data consistency checks and quality reviews.
Education
- Degree in Life Sciences, Pharmacy, or related field.
2. Drug Safety Specialist (SDEA – Pharmacovigilance)
Job ID: R0000033067 | Location: Hyderabad (Mindspace)
Job Description
- Manage Safety Data Exchange Agreements (SDEAs/PVAs) for global compliance.
- Review PV obligations (ICSRs, PSURs, RMPs, Signal Detection).
- Maintain contract databases, track expirations, and ensure timely updates.
- Support aggregate report teams (PSURs/DSURs).
- Conduct training sessions and ensure compliance with SOPs & regulatory guidelines.
Experience & Skills Required
- 2-3 years in pharmacovigilance/drug safety/contract management.
- Strong knowledge of FDA, EMA, ICH guidelines.
- Proficiency in safety databases & MS Office.
Education
- Bachelor’s/Master’s in Life Sciences, Pharmacy, or related field.
3. Senior Drug Safety Physician
Job ID: R0000033564 | Location: Remote (Mohali/Hyderabad)
Job Description
- Provide medical review of Adverse Events (AEs) & Adverse Drug Reactions (ADRs).
- Assess seriousness, expectedness, and causality of reported cases.
- Support pharmacovigilance inspections & audits.
- Mentor junior team members and act as a Subject Matter Expert (SME).
Experience & Skills Required
- Minimum 2 years in Pharmacovigilance/Drug Safety.
- Strong understanding of GCP, GVP, and global regulatory requirements.
Education
- MBBS or Post-Graduation in Medicine.
Why Join Parexel?
✅ Global Impact: Contribute to life-saving therapies.
✅ Career Growth: Work with industry experts.
✅ Flexible Work: Remote opportunities available.
✅ Innovative Culture: Cutting-edge pharmacovigilance & drug safety practices.
How to Apply?
Application Link for Medical Writer I
Application Link for Drug Safety Specialist (SDEA – Pharmacovigilance)
Application Link for Senior Drug Safety Physician
