Pharma Job 2026 | Pharmacovigilance Job Opportunity at Parexel | B Pharm Graduates Apply now
Are you searching for a Pharmacovigilance Job in a reputed global CRO? The Patient Safety Associate I Pharma Job at Parexel is an excellent opportunity for Pharma graduates looking to build a strong career in drug safety and regulatory reporting. This Pharma Job offers hands-on experience in ICSR processing, safety submissions, regulatory intelligence, and literature review across Hyderabad, Bengaluru, and Mohali locations.
- Job Title: Patient Safety Associate I
- Location: India, Hyderabad
- Job ID: R0000039196
About the Company
Parexel is a globally recognized Clinical Research Organization (CRO) delivering clinical development, regulatory consulting, and pharmacovigilance services. This Pharmacovigilance Job provides exposure to global safety databases, regulatory compliance frameworks, and client-focused drug safety operations.
Job Description
This Pharmacovigilance Job involves supporting global drug safety operations, including ICSR processing, safety submissions, regulatory intelligence, affiliate services, and literature review. The Pharma Job focuses on ensuring compliance with global reporting timelines, maintaining data accuracy, and supporting regulatory requirements.
Key Responsibilities
- Develop knowledge of safety profiles, labeling, and global regulations
- Follow established project-specific procedures and workflows
- Support basic compliance with regulatory reporting timelines
- Assist with preparation for audits and inspections
- Participate in internal and client-specific training sessions
- Ensure timely and accurate completion of Timesheets
ICSR Processing
- Monitoring of incoming reports from various sources such as mailboxes, EudraVigilance, literature searches, etc.
- Perform literature searches as per the search strategy and perform data entry of valid cases into the safety database
- Triage of incoming reports for completeness, legibility, and validity
- Prepare Adverse Drug Reaction (ADR) form/coversheet as required
- Perform MedDRA coding in accordance with guidelines
- Prepare medically cohesive case narratives
- Perform quality checks/validation checks
- Maintain local drug safety reporting requirements
Safety Submissions
- Submit Individual Case Safety Reports (ICSRs) and Periodic Reports to Regulatory Authorities
- Perform unblinding treatment codes for safety reporting
- Develop project-specific Global Safety Reporting Procedures
- Maintain compliance metrics and reporting schedules
- Prepare and file project-specific documents in EDMS/eTMF
- Participate in audits and inspections
Literature Review
- Formulate and maintain search strategies
- Screen and evaluate literature for potential ADRs and safety signals
- Peer-reviewed literature abstracts/articles
- Flag relevant findings for medical review
- Perform quality checks of search strategies
Affiliate Services
- Support communication between global safety operations and affiliates
- Assist with literature monitoring tasks
- Support data reconciliation activities
- Coordinate country-specific literature screening activities
Regulatory Support & Intelligence
- Manage regulatory applications and lifecycle changes
- Support global regulatory activities, including eCTD submissions and renewals
- Track safety reports such as RMP, PBRER, HASR, PASS
- Perform country safety requirement reviews
- Maintain up-to-date knowledge of relevant regulations and SOPs
Qualifications
- Degree in Life Sciences/Health or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, etc.) or equivalent qualification/work experience
- Foundational knowledge of drug safety regulations and pharmacovigilance processes
- Basic analytical and problem-solving abilities
- Good communication skills
- Basic understanding of healthcare terminology
- Strong desire to learn and develop skills in pharmacovigilance
- Related healthcare environment experience is an advantage
