Global clinical research organization (CRO) Medpace Clinical Research India is hiring for the position of Drug Safety Specialist/Clinical Safety Coordinator in Navi Mumbai, Maharashtra. This is an excellent opportunity for candidates with 1-3 years of pharmacovigilance, clinical research, or case processing experience who are looking to build a career in drug safety and clinical development.
The role involves handling adverse event reporting, safety case processing, safety narrative writing, and collaborating with clinical research sites to ensure compliance with global pharmacovigilance processes.
Job Details
| Particulars | Details |
|---|---|
| Position | Drug Safety Specialist / Clinical Safety Coordinator |
| Company | Medpace Clinical Research India |
| Location | Navi Mumbai, Maharashtra, India |
| Experience | 1-3 Years |
| Employment Type | Full-Time, Permanent |
| Industry | Pharmaceutical & Life Sciences |
| Department | Healthcare & Life Sciences |
About Medpace
Medpace is a leading global Contract Research Organization (CRO) that provides Phase I-IV clinical development services to biotechnology, pharmaceutical, and medical device companies worldwide. Headquartered in Cincinnati, Ohio, Medpace employs more than 6,000 professionals across 40+ countries and specializes in therapeutic areas including oncology, cardiology, endocrinology, metabolic disorders, CNS, and infectious diseases.
Key Responsibilities
As a Clinical Safety Coordinator, you will:
- Determine appropriate action plans for incoming safety reports and calls.
- Collect, process, and track adverse events (AEs) and serious adverse events (SAEs).
- Perform pharmacovigilance case processing activities from clinical trials and post-marketing sources.
- Write and review safety narratives.
- Prepare reports on various safety data and pharmacovigilance metrics.
- Collaborate with investigative sites and internal departments to ensure compliance with safety procedures.
- Support global drug safety and regulatory reporting activities.
Qualifications Required
Candidates applying for this Drug Safety Specialist job in Navi Mumbai should possess:
Educational Qualification
- Bachelor’s degree in a healthcare-related field such as:
- B.Pharm
- M.Pharm
- Pharm.D
- B.Sc Life Sciences
- M.Sc Life Sciences
- Nursing
- Pharmacology or related healthcare disciplines
Preferred Experience
- Clinical research experience
- Pharmacovigilance case processing experience
- Post-marketing surveillance experience
- Knowledge of adverse event reporting and safety databases
- Understanding of medical terminology and drug safety regulations
Required Skills
- Pharmacovigilance (PV)
- Drug Safety Case Processing
- Safety Narrative Writing
- Clinical Research Operations
- Medical Terminology
- Regulatory Compliance
- Scientific Writing
- Microsoft Office
- Strong communication and organizational skills
- English language proficiency
Why Join Medpace?
Medpace offers employees:
- Flexible work environment
- Competitive compensation and benefits
- Structured career growth opportunities
- Employee health and wellness programs
- Paid time off (PTO)
- Employee appreciation events
- Exposure to global clinical trials and pharmacovigilance activities
- Opportunities to work with leading pharmaceutical and biotechnology companies
Awards and Recognition
Medpace has been:
- Recognized by Forbes as one of America’s Most Successful Midsize Companies (2021-2024)
- Repeatedly honored with CRO Leadership Awards by Life Science Leader magazine for expertise, quality, reliability, and capabilities.
How to Apply
