215 First Street
Post Date: 08/10/2018
Job ID: 2096
Job Category: Clinical: Pharmacovigilance (PV)/Drug Safety
Pharmacovigilance (PV) Compliance is a senior PV leader and creative and resourceful thinker. The Director will establish and maintain a Compliance and PV Quality System in accordance with international regulations and guidelines. He/she must be proactive, hands-on with a sense of urgency.
- Establish Metrics and other monitoring systems to measure and verify compliance for senior management.
- Leads PV inspection readiness activities and coordinates for global inspection readiness.
- Maintain and update the PSMF with QPPV and Head of PV.
- Develop and maintain a PV Quality System for Standard Operating Procedures, auditing, CAPAs.
- Assisting in the development, implementation and management of a PV training program.
- Work with Quality Assurance and other functions to establish pharmacovigilance activities in the company.
- Identify gaps in Pharmacovigilance, solutions, and monitor completion.
- Develop with SMEs and maintain SOPs.
- Develop and maintain Pharmacovigilance Agreements and Safety Data Exchange Agreements. Monitor compliance with required activities according to executed agreements.
- Monitor aggregate/periodic report compliance, reconciliations; monitor quality, timeliness and performance; assist in process.
- Manage EEA QPPV and local QPPV communication, etc.
- Manage training and documentation for PV department and PV training company-wide, vendors, etc.
- Bachelor’ s or Master’ s Degree in Health or Medical sciences, degree in Pharmacy, Nursing or Public Health a plus
- 5-10 years experience in Drug Safety / Pharmacovigilance with at least 3 year compliance experience preferred
- Global PV regulation experience is preferred.
- Ability to maintain positive relationships with management, peers and cross-functional departments
- Traits include critical thinking, sense of urgency, diplomacy and professionalism.
- Recognized by former peers, colleagues, managers and direct reports for attributes congruent with