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Parexel is hiring Patient Safety Associate I in Hyderabad. This is an excellent opportunity for candidates passionate about pharmacovigilance, drug safety, and clinical research. The role supports global patient safety activities, including ICSR processing, literature review, signal detection support, regulatory submissions, and medical monitoring tasks.
If you’re looking to start or grow your career in drug safety, this job offers high learning exposure, a supportive team environment, and growth pathways within Parexel’s global safety operations.
🧪 Key Responsibilities
As a Patient Safety Associate I, your role will include:
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Drug Safety Operations
- Assist in developing project-specific safety workflows, templates, and procedures.
- Support safety database setup and User Acceptance Testing (UAT).
- Triage incoming case reports for completeness, validity, and legibility.
- Enter safety data into PV databases and perform quality checks.
- Handle follow-up queries, coding, and case narrative writing.
- Maintain project documents, case files, and safety tracking logs.
- Support Medical Directors/Safety Physicians in medical monitoring.
Regulatory & PV Compliance
- Perform literature searches and document findings.
- Assist with audit/inspection preparation.
- Support expedited reporting procedures, unblinding of SUSARs, and case submissions via ISIS.
- Track regulatory submissions and measure reporting compliance.
- Assist with global regulatory registrations for electronic reporting.
🎓 Required Qualifications
- Education:
- Postgraduate in Pharmacy, Pharmacovigilance & Clinical Research, OR
- Bachelor in Dentistry (BDS)
- Experience in a healthcare or clinical environment is an added advantage.
- Good knowledge of database usage, literature search tools, and computer applications.
⭐ Key Skills
- Strong analytical and problem-solving abilities
- Excellent written and verbal communication
- Solid organization & prioritization skills
- Team coordination and client-focused approach
- Ability to work effectively in a global environment
💼 Benefits of Working at Parexel
- Exposure to global pharmacovigilance projects
- Supportive learning-driven environment
- Opportunities for career advancement in drug safety
- Work with cross-functional medical & regulatory teams
- Access to continuous training and development programs
📅 Application Deadline
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