Drug Safety Associate-II
Company: Parexel
Location: Mohali
Qualification: B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, Lifesciences, Nursing
Experience: 1 – 2 years
Salary: ₹25,000 – ₹35,000 /month
About the Company
At Parexel, we share a common goal – to improve the world’s health. Our clinical trials, regulatory, consulting, and market access services are driven by a deep conviction in our mission. Each team member contributes to the development of therapies that ultimately benefit patients. We work with empathy and commitment, making a difference in healthcare.
Key Responsibilities
- Assist in developing project-specific safety procedures, workflows, and templates
- Setup safety database, develop data entry guidelines, and perform user acceptance testing
- Triage incoming reports for completeness and validity
- Document and quality control of drug safety information
- Data entry of case reports into safety database/tracking system
- Request follow-up and perform query management
- Code data in the safety database
- Write case narratives
- Maintain project-specific working files and case report files
- Assist Drug Safety Specialists and Safety Service Project Leaders (SSPL) as needed
- Inform management of potential changes in project scope
- Support Medical Directors/Safety Physicians in medical monitoring activities
- Participate in client and investigator meetings
- Attend training sessions
- Perform literature searches
- Prepare for and follow-up on audits and inspections
- Delegate work to Drug Safety Assistants
- Develop expedited reporting procedures
- Register for electronic reporting on behalf of the sponsor
- Set up worldwide reporting to regulatory authorities and investigators
- Submit safety reports via ISIS (International Safety Information System)
- Track and file submission cases
- Assist with unblinding of SUSARs
- Collect and review metrics for reporting compliance
Skills and Requirements
- Education: Bachelor’s degree in health-related field
- Experience: Minimum 2 years experience in ICSR case processing
- Skills:
- Analytical and problem-solving
- Database/literature search proficiency
- Excellent interpersonal and communication skills
- Organizational and prioritization abilities
- Collaborative team player
- Client-focused
- Computer application proficiency
How to Apply
pranali.sarvagod@encubeethicals.com
