Drug Safety PV Compliance Manager
Drug Safety PV Compliance Manager
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Salary Not Disclosed
1 Vacancy
Job Description
Responsible for Pharmacovigilance (PV) Compliance and strengthening and advancing Neurocrines pharmacovigilance quality management system. Serves as an expert in global pre and postmarketing safety compliance and will manages all DSPV quality and compliance activities. Works independently and acts as PV Compliance liaison crossfunctionally within Neurocrine as well as to Neurocrines PV vendors and business partners.
Your Contributions (include but are not limited to):
- Manage all DSPV quality and compliance activities for programs in development and post approval including establishing compliance metrics and compliance monitoring
- Manage deviations and CAPAs (corrective and preventative actions)
- Facilitate SOP and guidelines development and revisions as well as training
- Manage inspection readiness activities and participate in audits
- Play a key role in supporting the development and maintenance of Pharmacovigilance System Master File (PSMF).
- Establish regulatory reporting requirements matrices per global requirements
- Lead process improvements projects within DSPV
- Other duties as assigned
Requirements:
- BS/BA in related scientific field or RN degree and 6 years of experience in drug safety in the biotech/pharmaceutical industry with 3 years of pharmacovigilance compliance experience. Preferred experience: Experience in supporting regulatory authority inspections of GVP and process improvement initiatives. Experience with drug safety databases such as Argus. Healthcare professional and vendor management experience preferred OR
- Masters degree in related scientific field and 4 years of similar experience noted above OR PharmD PhD PA in related scientific field and 4 years of similar experience noted above Some managerial / functional management or lead experience is a plus
- Strong knowledge of US and EU pharmacovigilance regulatory requirements.
- Strong knowledge of current pharmacovigilance practices.
- Ability to evaluate interpret and synthesize scientific data.
- Expert knowledge in global pre and postmarketing safety manages all DSPV quality and compliance activities
- Strong knowledge of regulatory authority inspection process with a focus on pharmacovigilance.
- Understanding of audit/compliance program design
- Experience with PSMF development and maintenance
- Strong knowledge of drug safety databases experience with Argus Safety is a plus
- Strong technical skills
- Requires understanding of how the team / work area relates to other related areas and uses that knowledge to improve efficiency and produce highquality work on problems with crossfunctional impact
- Identifies and resolves operational and organizational problems/problems relating to own discipline
- Frequently works crossfunctionally as the representative for their area
- Team player with ability to function in a multidisciplinary environment
- Selfmotivated detail oriented and able to prioritize and plan effectively
Employment Type
Full Time
