Job Summary
A commercial-stage research-based biotechnology company has a current position open for a Remote Drug Safety ICSR and ASR Senior Manager.
Core Responsibilities of this position include:
- Executing and supporting oversight of case processing activities
- Identifying elements needed to characterize SUSARs and IND Safety Reports
- Ensuring the adherence to defined coding and ICSR processing standards
Applicants must meet the following qualifications:
- Bachelors in life sciences, RN, RPh/PharmD, or the equivalent combination of relevant education or experience
- 5-6 years relevant experience in drug safety/pharmacovigilance
- Strong understanding of Global regulatory requirements for capture and submissions of pharmacovigilance
- Thorough understanding of case processing activities
- Clinical knowledge of therapeutic area patient populations and drug class
- Adept in development and monitoring of key performance indicators, compliance and quality metrics
