Parexel is hiring Drug Safety Specialists to support clinical trial and post-marketed drug safety management. If you have experience in pharmacovigilance, regulatory submissions, and medical monitoring, this is a great opportunity to join a global leader in the pharmaceutical industry.
Job Details
Location: Mohali, India
Position: Drug Safety Specialist
Job ID: R0000030170
Category: Medical Sciences
Key Responsibilities:
- Maintain knowledge of adverse event safety profiles, labeling documents, and global drug safety regulations.
- Ensure compliance with international and local regulatory reporting requirements.
- Develop project-specific safety procedures and workflows.
- Support audits, inspections, and client performance metrics.
- Mentor new recruits and assist senior management.
- Monitor Individual Case Safety Reports (ICSRs) from various sources.
- Ensure accuracy in seriousness criteria, causality assessment, and MedDRA coding.
- Process safety data, perform literature searches, and manage safety database entries.
- Generate safety reports and support regulatory submissions.
- Conduct and maintain search strategies for scientific and medical literature articles.
- Identify relevant publications for regulatory and safety reporting.
- Collaborate with internal/external stakeholders to resolve issues.
Required Skills & Competencies:
- Strong knowledge of drug safety, pharmacovigilance, and global safety regulations.
- Experience in data analysis, medical evaluation, and literature searches.
- Excellent communication, problem-solving, and presentation skills.
- Proficiency in Microsoft Office, database management, and web-based applications.
- Strong organizational and analytical skills.
Qualifications & Experience:
- Degree in Life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.).
- Medical, Dentistry, Physiotherapy, or Nursing degree is an advantage.
- 4+ years of experience in drug safety/pharmacovigilance preferred.
- Good knowledge of medical terminology.
How to Apply?
- Apply Now: Parexel Careers
- Email: indiacareers@parexel.com
- Subject Line: “Application for Drug Safety Specialist – Mohali”
See also Stallion Laboratories – Urgent Openings for Quality Control / Quality Assurance Departments
Why Join Parexel?
- Global Impact: Work with a leading pharmaceutical company on cutting-edge drug safety initiatives.
- Career Growth: Expand your expertise in regulatory affairs, pharmacovigilance, and medical monitoring.
- Collaborative Culture: Be part of an experienced, innovative, and supportive team.
Apply today and make an impact in drug safety and patient care!
