Clinilaunch Research Institute Llp
Location
Bangalore | India
Job description
This is a full-time on-site role in Bengaluru for a Drug Safety Associate. The Drug Safety Associate will be responsible for tasks such as
- Reviewing safety data, writing narratives, performing quality control checks, and ensuring regulatory compliance.
- Assisting in reviewing document quality while tracking regulatory publishing data in internal systems and uploading it to internal and/or external electronic trial master files.
- Ensuring redactions for Commercially Confident Information and Personal Data for regulatory publishing are maintained.
- Assisting in maintaining the upkeep of licenses within internal and/or external systems for users across projects within Security standards.
- Assisting with archiving regulatory publishing documents and submissions.
Qualifications
- Strong skills in Narrative writing and Medical Coding.
- Ability to perform Quality Control checks and ensure Regulatory Affairs compliance.
- Knowledge of Pharmacy and experience in drug safety.
- Excellent attention to detail and organizational skills.
- Strong written and verbal communication skills.
- Bachelors or Master s degree in Pharmacy.
- Experience with safety databases and knowledge of pharmacovigilance regulations is a plus.
Job tags
Salary
