A company is recruiting for the position of Drug Safety Associate – Clinical Safety and Pharmacovigilance in Noida, Uttar Pradesh. This opportunity is suitable for candidates with 0–1 year of experience in drug safety or pharmacovigilance and qualifications such as B.Pharm, M.Pharm, or BDS.
The role involves adverse event case processing, safety database review, medical literature assessment, pharmacovigilance project support, and compliance with applicable regulatory guidelines.
Job Details
| Particulars | Details |
|---|---|
| Job Title | Drug Safety Associate – Clinical Safety and Pharmacovigilance |
| Location | Noida, Uttar Pradesh |
| Experience | 0–1 year |
| Employment Type | Full-time |
| Qualification | B.Pharm / M.Pharm / BDS or equivalent qualification |
| Functional Area | Drug Safety / Pharmacovigilance |
Position Overview
The Drug Safety Associate will support clinical safety and pharmacovigilance operations by reviewing and recording adverse reactions, assessing medical literature, maintaining quality documentation, and ensuring assigned tasks meet regulatory requirements and project timelines.
Roles and Responsibilities
- Record and review adverse reactions in safety databases for post-marketing and clinical trial reports.
- Ensure accurate and high-quality case processing in accordance with applicable regulatory standards.
- Review literature abstracts and full-text articles.
- Communicate with relevant stakeholders to support operational activities.
- Perform administrative duties associated with the role.
- Support pharmacovigilance projects involving case processing, literature monitoring, aggregate reporting, medical writing, signal detection and management, medical information, and risk management.
- Maintain quality, compliance, and documentation across pharmacovigilance projects.
- Take ownership of assigned projects and tasks and meet quality and timeline requirements.
- Perform other responsibilities assigned by management.
Eligibility Criteria and Qualifications
Candidates must have one of the following qualifications:
- B.Pharm (Bachelor of Pharmacy)
- M.Pharm (Master of Pharmacy)
- BDS (Bachelor of Dental Surgery)
- Equivalent qualification from a reputed institute recognized by the Pharmacy Council of India.
Experience: 0–1 year in drug safety or pharmacovigilance.
Key Skills and Knowledge Areas
- Adverse event reporting and safety database review.
- Clinical trial and post-marketing safety reports.
- Medical literature assessment.
- Pharmacovigilance case processing.
- Literature monitoring and aggregate reporting.
- Medical writing and signal detection.
- Medical information and risk management.
- Quality assurance, regulatory compliance, and documentation.
- Stakeholder communication and timeline management.
