Parexel is a global leader in clinical research and regulatory services, dedicated to improving the world’s health. The company provides clinical development solutions, regulatory consulting, and market access services, all driven by a deep conviction in their mission. At Parexel, employees work with empathy and commitment, contributing to the development of life-saving therapies.
Responsibilities in the Job
As a Drug Safety Associate I at Parexel, you will play a crucial role in drug safety and pharmacovigilance. Your key responsibilities will include:
- Assisting in the development of project-specific safety procedures, workflows, and templates.
- Supporting project-specific safety database setup, including data entry guidelines and user acceptance testing.
- Reviewing incoming reports for completeness, legibility, and validity.
- Documenting and maintaining quality control of drug safety information electronically.
- Entering case reports into the safety database/tracking system.
- Managing queries and follow-ups for drug safety cases.
- Coding data in the safety database and writing case narratives.
- Preparing and maintaining project-specific working files and case reports.
- Providing support to Safety Service Project Leaders (SSPL) and Medical Directors.
- Participating in client and investigator meetings.
- Assisting in literature searches and preparing for audits and inspections.
- Helping with the development of expedited reporting procedures and compliance tracking.
- Submitting safety reports to investigators and relevant authorities.
Qualifications
To be eligible for the Drug Safety Associate I position at Parexel, candidates should have:
- A degree in M.Pharm, Pharm D, BDS, or MSc (Pharmacovigilance/Clinical Research).
- Related experience in a healthcare environment is advantageous.
Required Skills
Candidates should possess the following skills:
- Strong analytical and problem-solving skills.
- Ability to perform database/literature searches.
- Excellent verbal and written communication skills.
- Strong interpersonal and teamwork abilities.
- Effective organizational and prioritization skills.
- Client-focused approach to work.
- Proficiency in computer applications and databases.
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