Are you passionate about improving global health and ensuring drug safety? Parexel, a leading global biopharmaceutical services organization, is hiring for the position of Drug Safety Associate I in Mohali, India. This is a full-time opportunity to join a team dedicated to making a difference in patients’ lives. If you have a background in pharmacy, nursing, life sciences, or a related field, this could be the perfect role for you.
About Parexel
At Parexel, we are driven by a shared mission to improve the world’s health. From clinical trials to regulatory consulting and market access, our work is rooted in a deep commitment to making a difference. Every team member plays a vital role in developing therapies that benefit patients worldwide. We take pride in our empathetic approach and unwavering dedication to excellence.
Job Description
As a Drug Safety Associate I, you will provide technical and process-related support for drug safety management, including clinical trial and post-marketing activities. Your role will ensure compliance with regulatory requirements and Standard Operating Procedures (SOPs).
Key Responsibilities
- 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 data entry of case reports into the safety database and manage follow-up queries.
- Code data in the safety database and write case narratives.
- Maintain project-specific working files and case report files.
- Support Medical Directors/Safety Physicians in medical monitoring activities.
- Participate in client and investigator meetings as required.
- Prepare for and participate in audits and inspections.
- Assist with expedited reporting procedures and regulatory submissions.
- Track and file submission cases and measure investigative site performance.
Skills Required
- Strong analytical and problem-solving skills.
- Proficiency in database and literature searches.
- Excellent interpersonal, verbal, and written communication skills.
- Strong organizational and prioritization abilities.
- Ability to work collaboratively in a team environment.
- Client-focused approach to work.
- Experience with computer applications.
Qualifications
- Master’s degree in Pharmacy, Nursing, Life Sciences, or a related health field.
- Equivalent qualifications or work experience will also be considered.
- Prior experience in a healthcare environment is an advantage.
Why Join Parexel?
- Be part of a global organization committed to improving patient health.
- Work in a collaborative and supportive team environment.
- Gain valuable experience in drug safety and regulatory compliance.
- Opportunities for professional growth and development.
