Senior Manager, Drug Safety – Pharmacovigilance Operations
Neurelis, Inc.
full-time
Posted on:
Location Type: Remote
Location: California • United States
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Salary
💰 $162,000 - $180,000 per year
Job Level
About the role
- Responsibility for managing safety and PV related activities involving VALTOCO® and investigational compounds
- Supervision of external pharmacovigilance vendors regarding the collection, processing, and reconciliation of drug safety information
- Support the development of periodic safety reports to meet regulatory submission obligations
- Participate in cross-departmental discussions on reportable events and function as a drug safety/PV contact for both internal colleagues and external stakeholders
- Participate in the maintenance of the Global Safety Database and help develop global drug safety reporting procedures
Requirements
- BS in life sciences/pharmacy/nursing or related field required
- A minimum of 8 years’ experience with a pharmaceutical or biotech company
- Solid understanding and working knowledge of US and ex-US pharmacovigilance regulatory requirements (e.g., US Code of Federal regulations; European Union GVP legislation; and ICH Guidelines)
- Demonstrated success with drug safety case processing, combined with a thorough knowledge of drug safety systems and applications
- Able to effectively manage vendors related to drug safety/pharmacovigilance operations
- Prior experience in oversight and handling both expedited and non-expedited ICSRs
- Excellent communication and organization skills.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
drug safety case processingpharmacovigilanceGlobal Safety Databasedrug safety reporting proceduresregulatory submissionUS pharmacovigilance regulatory requirementsex-US pharmacovigilance regulatory requirementsICH GuidelinesEuropean Union GVP legislation
Soft Skills
communication skillsorganizational skillsvendor management
Certifications
BS in life sciencesBS in pharmacyBS in nursing