We are hiring a Drug Safety Specialist to join our dynamic team in Hyderabad. This role involves technical and process-related support for drug safety management, spanning both clinical trial and post-marketing activities. The ideal candidate will ensure compliance with global regulations, maintain high-quality standards, and collaborate on safety processes that align with Standard Operating Procedures (SOPs)
Key Responsibilities
- ICSR Management:
- Process Individual Case Safety Reports (ICSRs) from various sources, ensuring compliance with local and international regulatory requirements.
- Perform literature searches and review to identify relevant case reports for inclusion.
- Signal detection and management to identify potential safety issues.
- Track regulatory information and ensure timely regulatory submissions.
- Support the preparation of aggregate reports and study reports as needed.
- Compliance & Quality Monitoring:
- Perform quality reviews of ICSRs to ensure compliance with regulatory guidelines.
- Generate metrics and conduct investigations for late case reporting.
- Maintain compliance with International Conference on Harmonisation (ICH) and local reporting requirements.
- Medical and Product Dictionary Management:
- Oversee Medical Dictionary (MedDRA) and product dictionary management activities, where applicable.
Required Qualifications and Skills
- Educational Background:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or Medical Sciences.
- Experience:
- Experience in pharmacovigilance (PV) or drug safety operations, particularly handling ICSRs and regulatory submissions.
- Technical Skills:
- Familiarity with pharmacovigilance software tools for case processing and reporting.
- Knowledge of MedDRA and WHO Drug Dictionary management is a plus.
- Experience in literature screening, signal detection, and regulatory tracking.
- Soft Skills:
- Strong attention to detail and problem-solving abilities.
- Excellent communication and interpersonal skills.
- Ability to work efficiently under tight deadlines in a fast-paced environment.
