Drug Safety Associate II at parexel – SAS Nagar (Mohali)
Job Posting: Drug Safety Associate II
Location: SAS Nagar (Mohali), Punjab, India
Job ID: R0000025864
Category: Medical Sciences
About the Role
The Drug Safety Associate II will play a key role in ensuring the safety and compliance of drug safety activities. The ideal candidate will assist in the development and maintenance of safety procedures, perform data entry, manage case reports, and support various drug safety functions.
Responsibilities
- Drug Safety Support
- Assist in developing project-specific safety procedures, workflows, and templates.
- Aid in setting up project-specific safety databases and developing data entry guidelines.
- Conduct electronic documentation and quality control of drug safety information.
- Enter case reports into the safety database and tracking systems.
- Manage query follow-ups and perform coding of data.
- Write case narratives and maintain project-specific working files and case report files.
- Support Drug Safety Specialists and Safety Service Project Leaders as needed.
- Safety Reporting and Compliance
- Assist in the development of Expedited Reporting Procedures.
- Help with registration for electronic reporting and setting up worldwide reporting.
- Submit safety reports to investigators and assist with unblinding of SUSARs.
- Track and file submission cases and support collection and review of metrics.
- Client and Team Interactions
- Participate in client and investigator meetings as required.
- Attend internal drug safety and project-specific training sessions.
- Support Medical Directors/Safety Physicians in medical monitoring activities.
- Additional Duties
- Perform literature searches.
- Prepare for and participate in audits and inspections.
- Delegate tasks to Drug Safety Assistants as appropriate.
Skills
- Strong analytical and problem-solving skills.
- Proficient in database and literature searches.
- Excellent interpersonal, verbal, and written communication skills.
- Exceptional organizational and prioritization abilities.
- Ability to work collaboratively in a team environment.
- Client-focused approach to work.
- Experience with computer applications.
Knowledge and Experience
- Related experience in a healthcare environment is advantageous.
- Understanding of Good Clinical Practice (GCP) and global pharmacovigilance.
- Experience in a quality, compliance, or case processing role is highly desirable.
- Experience with Microsoft Excel and PowerPoint required.
Education
- Bachelor’s Degree in a relevant discipline (Science, Medical, etc.).
- Minimum of 3 years of pharmaceutical industry experience or 2 years of pharmacovigilance experience.
Application Details