Dana D.
Senior Drug Safety Specialist
- Role
- Senior Drug Safety Associate at Collegium Pharmaceutical, Inc.
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Dana D.
Motivated Registered Nurse with emphasis in patient care and leadership. 5+ years’…
Experience
Senior Drug Safety Associate
Collegium Pharmaceutical, Inc.
May 2025 — Present · US
Prepares aggregate safety reports, including establishment of timelines, content and project management, safety database report requests, review of data, and compilation of information• Collaborates with Regulatory Affairs and other functions to coordinate submission of aggregate safety reports• Collaborates with Quality, Standards & Training to ensure aggregate safety report procedures, training, and activities are sufficiently defined and maintained.• Participates in departmental development activities including SOP and Work Instruction development, Audits and Inspections.• Processing and assessing SAEs from receipt to case closure in the Argus database, including query generation, narrative, and ASE writing.• MedDRA coding of SAEs and AEs as reported in source documents of SAE reports and development/revision MedDRA Coding Conventions to ensure consistent data categorization.• Defining and applying a high standard of case quality review to ensure sound medical safety data documentation with the support of the Drug Safety Physician.• Scheduling submissions of expedited safety reports in ARGUS as needed.
Education
Bowie State University
Bachelor Science
University of Maryland
Bachelor of Science
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