California Licensed Patient Safety Manager
Job Summary
To support safety and pharmacovigilance initiatives, the part-time California Licensed Patient Safety Manager will manage compliance processes, oversee vendor activities, and lead audits while working remotely.
Key responsibilities
- Support process improvement and gap analysis for pharmacovigilance (PV) compliance
- Manage authoring and oversight of safety data exchange agreements and PV agreements
- Lead audit and inspection readiness activities, serving as a subject matter expert for internal and partner audits
Required qualifications
- Bachelor's degree in nursing, pharmacy, or other healthcare-related fields
- 4+ years in the pharmaceutical industry, with 2+ years in Safety and Pharmacovigilance focused on quality and compliance
- Oncology experience is required
- Strong knowledge of FDA, EMA, Asia-PAC, and ICH regulations and guidelines
- Expertise in safety quality systems and compliance monitoring
Complete Job Description
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