Job Opportunity: Drug Safety Specialist / Clinical Safety Coordinator
Job Summary
Medpace, a global leader in the Contract Research Organization (CRO) industry, is currently seeking dedicated nursing professionals to join our team in Navi Mumbai as Drug Safety Specialists / Clinical Safety Coordinators. This role is an excellent entry-to-mid-level opportunity for clinicians looking to transition into the dynamic field of pharmacovigilance and clinical research. You will play a pivotal role in ensuring patient safety by managing and reporting adverse events within global clinical trials.
About Medpace
Medpace is a premier, full-service Contract Research Organization (CRO) headquartered in Cincinnati, USA. We provide comprehensive clinical development services to the biotechnology, pharmaceutical, and medical device industries across more than 40 countries. Our mission is to accelerate the development of safe and effective medical therapies, with a strong focus on therapeutic areas such as oncology, cardiology, neurology, and infectious diseases.
Responsibilities
As a Clinical Safety Coordinator, you will be integral to the lifecycle of Individual Case Safety Reports (ICSRs). Your core responsibilities will include:
- Adverse Event Processing: Manage the intake, triage, and processing of Adverse Events (AEs) and Serious Adverse Events (SAEs) from a variety of sources.
- Documentation: Draft precise safety narratives for ICSR documentation to ensure high-quality, compliant data.
- Data Management: Track and maintain safety data, ensuring complete accuracy and adherence to strict regulatory standards and internal Standard Operating Procedures (SOPs).
- Stakeholder Collaboration: Act as a point of contact for clinical research sites and internal project teams to resolve safety-related queries.
- Regulatory Compliance: Support post-marketing surveillance and clinical trial safety operations to ensure all reporting meets global pharmacovigilance guidelines.
- Follow-up Activities: Execute timely follow-up actions to ensure all necessary safety information is captured and verified.
Requirements
We are looking for motivated candidates who possess both a strong clinical foundation and a desire to build a career in pharmacovigilance. To be considered for this role, you must meet the following criteria:
- Educational Background: A degree in Nursing is mandatory.
- Clinical Knowledge: Demonstrated understanding of medical terminology and human physiology.
- Communication Skills: Strong verbal and written communication skills in English are essential for interacting with international stakeholders.
- Technical Proficiency: Ability to work efficiently with Microsoft Office suite and internal databases.
- Soft Skills: Strong organizational skills, attention to detail, and the ability to manage competing priorities in a fast-paced environment.
Compensation & Benefits
We believe in investing in our employees’ professional growth and well-being. Medpace offers:
- Competitive Salary: Anticipated range of ₹4.5 LPA – ₹8 LPA, commensurate with experience and industry benchmarks for the CRO sector.
- Career Development: Clear, structured pathways for growth within the clinical research and pharmacovigilance departments.
- Global Exposure: The opportunity to work on Phase I–IV clinical trials for top-tier global pharmaceutical and biotech clients.
- Work-Life Integration: A professional and flexible work environment.
- Employee Support: Comprehensive employee wellness programs and various internal recognition initiatives.
Job Location
This is an office-based position located in Navi Mumbai, India.
How to Apply
If you are a nurse looking to leverage your clinical background in a challenging and rewarding global industry, we encourage you to apply. Please submit your updated resume and cover letter via the official Medpace careers portal.
Apply for the Drug Safety Specialist / Clinical Safety Coordinator Role Here
Medpace is an equal opportunity employer. We value the expertise that clinicians bring to our safety teams and look forward to reviewing your application.
