Looking to expand your career in clinical safety and pharmacovigilance? Medpace, a leading clinical contract research organization (CRO), is hiring a dedicated Drug Safety Specialist in Navi Mumbai, India. This role in our Clinical Safety department involves working closely with teams to handle and process adverse events from diverse sources, including clinical trials and post-marketing surveillance.
Company Introduction
Medpace, headquartered in Cincinnati, Ohio, is a globally recognized, full-service CRO that provides Phase I-IV clinical development services. Serving the biotechnology, pharmaceutical, and medical device industries, Medpace’s mission is to expedite the development of safe and effective therapeutics. Known for its scientific, disciplined approach, the company boasts more than 5,000 professionals across 40+ countries and expertise in a wide array of therapeutic areas, including oncology, cardiology, endocrinology, and infectious diseases.
Responsibilities in the Role of Drug Safety Specialist
As a Clinical Safety Coordinator, you’ll play a critical role in safeguarding patient health. Responsibilities include:
- Determining action plans for adverse event (AE) calls: Formulating quick responses to ensure timely action.
- Adverse event tracking and processing: Collect, process, and meticulously track incoming adverse events, focusing on both clinical trials and post-marketing cases.
- Writing safety narratives: Summarize safety data for effective communication within Medpace and with external stakeholders.
- Data reporting: Compiling and analyzing safety data to support team decision-making.
- Interdepartmental collaboration: Working closely with clinical research sites and internal departments to ensure all safety processes align with regulatory standards.
Qualifications
Ideal candidates will bring a robust background in healthcare and clinical research to Medpace, with these qualifications:
- Educational background: Bachelor’s degree in Nursing, Pharmacy, Pharmacology, or other healthcare-related fields.
- Relevant experience: Clinical research experience, including case processing and post-marketing pharmacovigilance, is highly valued.
- Medical terminology proficiency: A broad understanding of medical terms is crucial for accurate adverse event documentation.
- Proficiency in Microsoft Office: Strong familiarity with Office applications for effective data tracking and reporting.
- Communication and organization skills: Excellent organizational abilities and strong communication skills, particularly in English.
Key Skills for Success
To excel in this role, candidates should possess:
- Strong analytical skills for accurate data processing
- A keen eye for detail to manage adverse event reports with precision
- Excellent interpersonal skills to collaborate across teams and with external research sites
- An agile approach to handle fast-paced, high-stakes situations involving patient safety.
