Location
Bangalore | India
Job description
Drug Safety Associates (DSAs)
DSAs play a vital role in ensuring the safety of pharmaceutical drugs and medical devices after they have been approved for marketing. DSAs are responsible for collecting, evaluating, and reporting adverse event reports (AERs) from patients, healthcare professionals, and other sources. They also work to identify and assess safety signals, which are patterns of AERs that may suggest a potential safety risk associated with a drug or device.
Responsibilities
- Review and evaluate AERs to determine if they meet regulatory reporting requirements
- Classify AERs according to their severity, causality, and other factors
- Prepare and submit regulatory reports to government agencies, such as the FDA
- Conduct signal detection and analysis to identify potential safety risks
- Provide medical information and support to healthcare professionals and patients
- Maintain knowledge of global regulatory requirements and best practices in drug safety
Qualifications
- Bachelor's degree in a related field, such as pharmacy, medicine, nursing, or life sciences
- Strong understanding of medical terminology and pathophysiology
- Experience with drug safety databases and reporting systems
- Excellent written and verbal communication skills
- Ability to work independently and as part of a team
Preferred Qualifications
- Master's degree in drug safety or a related field
- Experience with clinical trials
- Experience with pharmacovigilance software
- Fluency in a foreign language is a plus
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