Johnson & Johnson Careers

ASPAC IPV Affairs Lead

Shaanxi, China
Drug & Product Safety Operations

Job Description

Requisition ID: 1905725546W

- Serve as a Member of the Global IPV Affairs;
- Provide Line-Management to the ASPAC IPV Affairs Team by adhering to the applicable HR processes (e.g. five conversations) and ensure a harmonized approach is applied for all GMS employees in the Market;
- Be an ambassador of the Office of the Chief Medical Officer (OCMO) culture and vision;
- Ensure best practices and lessons learned are shared at Regional and Global Level;
- A member of the ASPAC IPV Leadership team;
- Work closely with ASPAC Medical Safety and ASPAC Case Processing Team to meet ASPAC business and compliance needs;
- Management and oversight of IPV key communication tools like IPV Monthly Reports, IPV and LSO Community SharePoint site, and IPV newsletter;
- Oversee global IPV Tracking systems (e.g.TFUQ, RMP, DD tracking, Reconcilation tracking) , drive improvements and increase efficiencies;
- Lead global implementation projects for new Procedures and Systems for IPV and coordinate IPV impact assessments to meet global standards and local applicable laws and needs. Function as direct contact point for GMS/ OCMS Operations;
- Support IPV in building and maintaining inspection readiness for all IPV related activities;
- Take ownership for global IPV processes in cooperation with relevant SMEs and stakeholders;
- Develop a globally consistent approach for assessing, recording and reporting of countries compliance status in close cooperation with CSA international. Escalate alert signals of non-compliance. Focus on risk identification and support mitigation as needed;
- Initiate and lead continuous improvement initiatives based on quality and compliance Key Performance Indicators;
- Contributing to the development of an standardized and integrated IPV quality system;
- Closely collaborate with CSA international to develop a Corrective and Preventive Action (CAPA) monitoring system and monitoring and follow-up on CAPAs, escalating non-adherence;
- Lead targeted IPV projects based on prioritization by the IPVLT to measurably improve global, regional and Local Operating Company PV compliance and efficiencies in operations. Identify trends across regions and highlight opportunities to IPV Leadership team;
- Coordinate and own regional, global IPV CAPAs as applicable;
- Ensure oversight and coordinate LSO assignments to regional and global projects (SMEs);
- Develop strategy for composition and maintenance of IPV Curricula in close cooperation with CSA International;
- Coordinate roll-out of new/revised role profiles and competency model;
- Oversee global strategy for onboarding programs and support regions to develop strategy for LSO onboarding programs;
- Develop strategy and coordinate global training for IPV team and employees of the Local Safety Units depending on current needs (e.g. Global LSO Trainings, Lessons of the month).

- 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 of responsibility within Pharmacovigilance;
- Proven leadership and management capability with the ability to simplify complex workflows and simultaneously manage critical issues in a complex and changing internal and external environment;
- Excellent people management, negotiation skills and leadership in coaching people in influencing internal and external partners;
- 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;
- 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.

Primary Location
Xian-Janssen Pharmaceutical Ltd. (7043)
Job Function
Drug & Product Safety Operations
Requisition ID