Job Summary
A contract research organization needs applicants for an opening for a Remote Drug Safety Associate 2.
Candidates will be responsible for the following:
- Developing project specific technical and planning documents in own functional area
- Supporting the generation of aggregated safety reports, and Data Monitoring Committees (DMC) reviews
- Providing management of individual case safety reports, reconciliation of SAEs, coding and data retrievals from the safety database
Applicants must meet the following qualifications:
- Basic knowledge of regulatory environment governing safety and risk management activities
- 2 to 3 years experience in processing of ICSR
- 2 to 3 years experience as a Clinical Data Coordinator, with at least one year experience as Lead Clinical Data Coordinator
- An equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job
- Undergraduate degree or its international equivalent, preferably in life science and/or healthcare professional
- Knowledge in pre- and post-marketing Pharmacovigilance
