Johnson & Johnson Careers
IPV Operations Manager
Requisition ID: 1805656085W
• Serve as a Member of the IPV Global Operations Team
• Be an ambassador of the Office of the Chief Medical Officer (OCMO) culture and vision
• Support and lead IPV Operations Task and projects as defined by business need
• Support the LOCs in building and maintaining audit and inspection readiness for all IPV related activities in close cooperation with Regional IPV teams
• Review of audit and inspection reports and support trending of observations to lead to overall improvements
• Contributing to the development of an integrated IPV quality system:
• Coordinating the review and the implementation of procedures and systems to meet global standards and local applicable laws.
• Coordination of Local implementation documentation (LIDs) in the region as applicable
• Contribute to the development of a quality monitoring system to assess compliance and mitigate risks
• Coordinate regular data/metrics delivery produced by LSOs or other sources
• Initiate and support continuous improvement initiatives based on quality and compliance Key Performance Indicators
• Support preparing the compliance oversight reports needed for the different stakeholders for final review by the IPV Leadership team
• Oversee timely delivery of the requested Pharmacovigilance System Master File (PSMF) annexes per IPV regions
• Ensure appropriate Quality checks being performed in accordance with PSMF Policies
• Oversee handling of contact data in Gmetrics and coordinate appropriate outputs e.g. assignment of trainings per role change, access to SP and DL etc.) in close cooperation with regional IPV Manager.
- Medical, pharmaceutical or nature science degree with proven expertise and experience in pharmaceutical industry and experience in Pharmacovigilance
- Minimum of 3 years experience in a position within Pharmacovigilance
- Proven management capability with the ability to simplify complex workflows and simultaneously manage critical issues in a complex and changing internal and external environment.
- Task-oriented with proven experience in the delivery of high quality work and able to operate autonomously without direct supervision and as part of a multi-disciplinary team
- In-depth understanding of vigilance systems and processes; knowledge of or experience with International Pharmacovigilance and compliance regulations and guidelines is an advantage for this role.
- Demonstrable insight to the development of regulatory requirements with knowledge of Global aspects of drug/cosmetics/devices safety, including International reporting requirements and relevant country-specific variations within EMEA.
- Proven Project Management experience including stakeholder management and change management experience.
- Excellent computer-based application skills
- Fluent communication skills in English, any additional language is a plus
Xian-Janssen Pharmaceutical Ltd. (7043)