Drug Safety Associate II at Parexel
| Position | Drug Safety Associate II |
|---|---|
| Company | Parexel |
| Experience Required | 2 Years |
| Salary Range | 4.5 – 7.4 Lacs per annum |
| Location | SAS Nagar (Mohali), India |
| Education Requirements | B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, Life Sciences |
| Application Mode | Online |
| Job Highlights | Work/Life Balance, Flexibility, Time Management, Problem Solving |
| Key Skills | Drug Safety Management, Database Handling, Compliance, Teamwork |
Join Parexel as a Drug Safety Associate II
The Drug Safety Associate II role at Parexel in Mohali focuses on drug safety support for clinical trials and post-marketing phases. Ideal for candidates with a background in pharmacy or life sciences, this position emphasizes drug safety management, compliance with regulatory standards, and effective team collaboration. Drug Safety Associate II at Parexel
Why Parexel?
Parexel is a global leader in biopharmaceutical services, offering innovative solutions in drug development and regulatory compliance. This role provides work/life balance, opportunities for skill enhancement, and career growth in a supportive environment focused on healthcare innovation. Drug Safety Associate II at Parexel
Role Overview
In this position, you’ll be responsible for maintaining drug safety by managing databases, facilitating medical monitoring, and preparing for audits and regulatory submissions. Key responsibilities include setting up safety databases, handling case reports, and supporting compliance processes in a collaborative environment. Drug Safety Associate II at Parexel
Key Responsibilities Breakdown
1. Drug Safety Management
- Project-Specific Procedures: Develop safety procedures and workflows tailored to individual projects.
- Database Setup and Maintenance: Manage safety databases, perform data entry, conduct quality control checks, and handle follow-up queries.
- Case Report Management: Code and enter data in the safety database, develop case narratives, and maintain all project-related documentation. Drug Safety Associate II at Parexel
2. Collaboration and Reporting
- Medical Monitoring Support: Assist Medical Directors and Safety Physicians with clinical safety monitoring.
- Regulatory Submissions: Help establish expedited reporting procedures, participate in audits, and ensure compliance with global safety reporting standards.
3. Additional Responsibilities
- Team Management: Delegate tasks, oversee team responsibilities, and conduct relevant literature searches.
- Compliance and Training: Track compliance metrics and engage in project-specific training sessions to maintain regulatory standards. Drug Safety Associate II at Parexel
Ideal Candidate Profile
Educational Background
A degree in Pharmacy, Nursing, Life Sciences, or equivalent is required. Candidates with an Associate degree and relevant experience may also be considered.
Experience and Skills
- Technical Skills: Expertise in drug safety databases, ICSR case processing, and database management.
- Problem-Solving Skills: Strong analytical abilities to ensure data accuracy and regulatory compliance.
- Communication and Interpersonal Skills: Proven client-focused approach and teamwork abilities.
- Organizational Skills: Ability to prioritize tasks in a fast-paced, regulatory-compliant environment.
Positioning Yourself as a Strong Candidate
To increase your chances of success:
- Emphasize Drug Safety Experience: Highlight your knowledge in drug safety database management, quality control, and ICSR case processing.
- Showcase Collaborative Skills: Demonstrate your experience in client interactions and teamwork.
- Focus on Regulatory Compliance: Mention familiarity with regulatory standards and global reporting processes.
Why This Role Could Be Right for You
The Drug Safety Associate II role at Parexel offers a great opportunity to develop your skills in drug safety management while contributing to global healthcare standards. With a focus on compliance, quality, and teamwork, this role is ideal for those passionate about advancing safety practices in clinical research.
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