Description
Responsibilities- Assess and process adverse events - including narrative writing
- Follow-up on clinical and post-marketed information necessary for AE completion
- Ensure prompt and accurate processing of reports to regulating agencies and other parties
- Update and develop SOPs
- Coding of SAE's and AE's -MedDRA
- Drafting or contributing to safety documents such as SMP's or safety exchange agreements
- Reconciliation between clinical and safety databases
Qualification
- BS or MS in Science or an HCP (PharmD or RN)
- 5+ years of relevant experience within industry
- ARGUS or similar safety database experience a plus
- Comprehension of Drug Development, safety reporting, FDA and ICH guidelines
- Strong organization and project management skills
- Strong oral and written communication
- Proactive, high intensity attitude, both supportive and constructive of projects and colleagues