Parexel is a leading global clinical research organization (CRO) dedicated to improving world health through innovative clinical trials, regulatory consulting, and market access solutions. With a strong commitment to patient safety and ethical research, Parexel plays a crucial role in bringing life-changing therapies to market.
At Parexel, every team member contributes to the development of treatments that benefit patients worldwide. The company fosters a collaborative, empathetic, and purpose-driven work environment where employees take pride in making a real difference in healthcare.
Job Description: Drug Safety Associate I
Key Responsibilities
As a Drug Safety Associate I at Parexel, you will provide essential support in drug safety management (clinical trial and post-marketed) and medical monitoring activities while ensuring compliance with regulatory standards and Standard Operating Procedures (SOPs).
Drug Safety Support:
- Assist in developing project-specific safety procedures, workflows, and templates.
- Support safety database setup, data entry guidelines, and user acceptance testing.
- Triage incoming reports for completeness, legibility, and validity.
- Perform electronic documentation and quality control of drug safety data.
- Enter case reports into safety databases and tracking systems.
- Manage follow-up requests and queries.
- Code data in safety databases and write case narratives.
- Maintain project-specific working files, case report files, and central files.
Regulatory & Compliance Support:
- Assist in expedited reporting procedures and regulatory authority registrations.
- Support worldwide safety report submissions to regulatory authorities, ethics committees, and investigators.
- Submit safety reports to investigators via ISIS (International Safety Information System).
- Track and file submission cases as required.
- Assist in unblinding SUSARs (Suspected Unexpected Serious Adverse Reactions) when necessary.
- Support compliance metrics collection and reporting.
Additional Responsibilities:
- Assist Safety Physicians and Medical Directors in medical monitoring.
- Participate in client and investigator meetings.
- Attend internal and project-specific training sessions.
- Conduct literature searches as needed.
- Support audits and inspections.
Required Skills & Qualifications
Essential Skills:
✔ Strong analytical and problem-solving abilities
✔ Proficiency in database and literature searches
✔ Excellent verbal and written communication
✔ Strong organizational and prioritization skills
✔ Ability to work effectively in a team
✔ Client-focused approach
Education & Experience:
- Degree in Pharmacy, Nursing, Life Sciences, or related healthcare field (or equivalent experience).
- Associate degree holders with relevant work experience may also apply.
- Prior experience in a healthcare or pharmacovigilance setting is a plus.
Why Join Parexel?
- Work in a globally recognized CRO with a strong industry reputation.
- Contribute to life-saving therapies and patient safety.
- Collaborative and supportive work culture.
- Opportunities for professional growth and development.
