Drug Safety Associate NEW ERA LIFE CARE PRIVATE LIMITED
NEW ERA LIFE CARE PRIVATE LIMITED
Office Location
Full Time
Experience: 10 - 10 years required
Pay: INR 800000 - INR 1800000 /year
Type: Full Time
Location: Ambala
Skills: Medical Terminology, medical affairs, Adaptability, protocols, Safety, drug interactions, Pharmaceutical Care, Pharmacovigilance, pharmaceutical medicine, Regulatory, Regulatory Compliance, knowledge, drug
About NEW ERA LIFE CARE PRIVATE LIMITED
Job Description
Job description
- Reviewing and evaluating adverse event reports to determine if they meet regulatory reporting requirements.
- Entering and maintaining adverse event information in safety databases
- Narrative writing
- Communicating with healthcare professionals and other stakeholders to gather additional information about adverse events
- Assisting in the preparation of safety reports to be submitted to regulatory agencies
- Monitoring safety literature to stay current on the latest safety information related to the products
- Collaborating with other departments such as clinical research, regulatory affairs, and pharma covigilance to ensure compliance with safety regulations and guidelines
- Participating in the development and implementation of safety policies and procedures
- Reviewing and assessing the safety profile of new and existing products
- Participating in the development and execution of risk management plans
- Communicating with regulatory authorities, healthcare professionals, and other stakeholders on safety-related issues.