Job Title: Drug Safety Specialist / Clinical Safety Coordinator
Location: Navi Mumbai, India
About Medpace:
Medpace is a leading global Clinical Research Organization (CRO) dedicated to scientific excellence and patient-centric clinical trials. With a presence in over 40 countries and a team of over 5,000 professionals, we are committed to advancing healthcare through innovative research and a collaborative spirit. We are recognized for our quality, reliability, and expertise, consistently earning accolades such as Forbes’ “America’s Most Successful Midsize Companies” and CRO Leadership Awards.
Summary:
Are you a healthcare professional with a passion for patient safety and a keen eye for detail? Medpace is seeking a dedicated Drug Safety Specialist / Clinical Safety Coordinator to join our growing team in Navi Mumbai, India. If you have a background in nursing, pharmacy, pharmacology, or a related field and are eager to contribute to global pharmacovigilance operations, this is an excellent opportunity to launch or advance your career in clinical safety. In this role, you will be responsible for handling, processing, and reporting on adverse events from clinical trials and post-marketing surveillance, ensuring regulatory compliance and contributing to the safety of patients worldwide.
Key Responsibilities:
As a Clinical Safety Coordinator at Medpace, your primary responsibilities will include:
- Adverse Event Management: Handle and process adverse events (AEs) and serious adverse events (SAEs) from various sources, ensuring accurate and timely documentation.
- Case Processing: Manage case processing activities for both clinical trials and post-marketing surveillance, adhering to established protocols and timelines.
- Safety Call Management: Determine appropriate action plans for incoming safety calls and reports, ensuring timely and effective responses.
- Safety Narrative Drafting: Draft comprehensive and detailed safety narratives and documentation for adverse events, contributing to the overall safety profile of investigational products.
- Collaboration and Communication: Collaborate with internal departments, including clinical operations, data management, and medical affairs, as well as external research sites, to ensure effective communication and regulatory compliance.
- Data Analysis and Reporting: Analyze and report on clinical safety data to support global pharmacovigilance operations, identifying potential safety signals and trends.
- Regulatory Compliance: Ensure all activities are conducted in compliance with relevant regulations, guidelines, and standard operating procedures (SOPs).
- Database Management: Maintain accurate and up-to-date safety databases, ensuring data integrity and consistency.
- Risk Assessment: Assist in identifying and assessing potential safety risks associated with investigational products.
- Continuous Improvement: Participate in process improvement initiatives to enhance the efficiency and effectiveness of the drug safety department.
Qualifications and Eligibility:
To be considered for this role, candidates must meet the following qualifications:
- Educational Background: Bachelor’s degree in a healthcare-related field, such as Nursing, Pharmacy, Pharmacology, or a related discipline.
- Experience: Prior clinical or pharmacovigilance experience is preferred but not required. Freshers with relevant educational background are encouraged to apply.
- Technical Skills: Proficient in medical terminology and Microsoft Office Suite (Word, Excel, PowerPoint).
- Communication Skills: Excellent English communication skills, both written and verbal, with the ability to effectively communicate complex information.
- Organizational Skills: Strong organizational skills with the ability to manage multiple tasks and prioritize workload effectively.
- Attention to Detail: Detail-oriented mindset with a strong commitment to data accuracy and regulatory standards.
- Analytical Skills: Ability to analyze and interpret clinical data to identify potential safety signals and trends.
- Regulatory Knowledge: Familiarity with relevant regulations and guidelines related to pharmacovigilance, such as ICH guidelines and local regulatory requirements.
- Teamwork: Ability to work effectively in a team environment, collaborating with colleagues and stakeholders to achieve common goals.
Why Join Medpace?
Medpace offers a stimulating and rewarding work environment where you can make a meaningful impact on patient health. We are committed to the professional growth and development of our employees, providing ample opportunities for career advancement.
Perks & Benefits:
- Competitive salary package (₹5–9 LPA) commensurate with experience and qualifications.
- Flexible work environment with a focus on work-life balance.
- Comprehensive PTO (Paid Time Off) policy to support your personal and professional needs.
- Employee health and wellness initiatives to promote a healthy lifestyle.
- Regular team events and appreciation programs to foster a sense of community and recognize employee contributions.
- Career growth opportunities with structured training and mentorship programs to support your professional development.
Awards & Recognition:
- Forbes “America’s Most Successful Midsize Companies” (2021–2024)
- Recipient of CRO Leadership Awards for Quality, Reliability, and Expertise
We invite you to join our team and contribute to our mission of advancing healthcare through innovative clinical research. If you are a motivated and passionate healthcare professional with a strong commitment to patient safety, we encourage you to apply.