The Drug Safety Associate II role in Mohali, India, is focused on supporting drug safety management in both clinical trials and post-marketing phases. This position requires ensuring compliance with regulatory guidelines, participating in safety database setup, managing case reports, and coordinating with various stakeholders to facilitate drug safety and medical monitoring activities.
Key Responsibilities
- Drug Safety Management:
- Develop project-specific safety procedures and workflows.
- Set up safety databases, perform data entry, conduct quality control, and manage follow-up queries.
- Code data in the safety database, create case narratives, and maintain project files.
- Collaboration and Reporting:
- Assist Medical Directors and Safety Physicians in medical monitoring.
- Prepare for and participate in client meetings, audits, and regulatory submissions.
- Help develop expedited reporting procedures and assist with global reporting to regulatory bodies.
- Additional Duties:
- Manage team tasks, delegate work as necessary, and conduct literature searches.
- Support compliance metrics tracking and participate in project-specific training.
Required Skills
- Technical Skills: Analytical, problem-solving, and database management.
- Interpersonal Skills: Strong communication and client-focused approach.
- Organizational Skills: Ability to prioritize and work effectively in team settings.
Qualifications
- Education: Degree in Pharmacy, Nursing, Life Sciences, or equivalent. An Associate degree with relevant experience may also be acceptable.
- Experience: At least 2 years in ICSR case processing and familiarity with database/literature searches.
Positioning Yourself as a Strong Candidate
To enhance your candidacy for this role:
- Highlight your experience in drug safety databases, ICSR case management, and quality control.
- Emphasize your collaborative skills and ability to prioritize tasks in a fast-paced, regulatory-compliant environment.
- Showcase your proficiency with technical tools and processes related to drug safety and reporting compliance.
