Parexel, a leading biopharmaceutical services company, is inviting applications for the position of Drug Safety Associate I. This full-time opportunity is based in Mohali, India. If you’re passionate about making a difference in global health through clinical trials, regulatory, and safety solutions, this role is for you.
About Parexel
At Parexel, we are united by our commitment to improving the world’s health. Our work spans clinical trials, regulatory consulting, and market access, all underpinned by a shared conviction in our mission. Every team member contributes to developing life-changing therapies that benefit patients globally.
Responsibilities of a Drug Safety Associate I
As a Drug Safety Associate I, you will play a crucial role in supporting drug safety management and medical monitoring activities. Your responsibilities include:
- Assisting in the development of project-specific safety procedures and templates.
- Conducting triage for incoming reports and ensuring their completeness and validity.
- Managing electronic documentation and quality control of drug safety information.
- Entering case reports into the safety database and handling query management.
- Writing case narratives and maintaining project-specific files.
- Supporting safety database setup and user acceptance testing.
- Assisting in regulatory compliance tasks, such as submission of safety reports.
- Preparing for and participating in audits and inspections.
Required Qualifications
To be successful in this role, candidates must meet the following qualifications:
- Educational Background: M. Pharmacy, BDS, Pharm D, or equivalent qualifications.
- Experience: Prior experience in a healthcare environment is an added advantage.
Skills and Competencies
The ideal candidate will possess:
- Strong analytical and problem-solving abilities.
- Proficiency in database and literature searches.
- Excellent communication and interpersonal skills.
- Effective organizational and time-management capabilities.
- A client-focused approach and ability to work collaboratively in a team setting.
