Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
Product SafetyJob Sub Function:
PharmacovigilanceJob Category:
People LeaderAll Job Posting Locations:
Beijing, China, North Ryde, New South Wales, Australia, Singapore, SingaporeJob Description:
Essential Job Duties and Responsibilities
POSITION SUMMARY:
The Regional Safety Head, Asia Pacific (APAC), Local Medical Safety is the senior safety leader for Pharma products for the APAC Region.
The Regional Safety Head, APAC will:
- Oversee Pharma product safety strategy and pharmacovigilance (PV) operations in the region while maintaining highest level of compliance with local regulations and JNJ global policies.
- Be the face of the Global Medical Organization (GMO) and Global Medical Safety (GMS) organization in the region and ensure the strategy is translated and deployed on a regional level.
- Oversee development and implementation of local Risk Management Plans and proactively address any emerging safety concerns. Ensure fulfillment of safety obligations adopted as part of marketing authorizations and other commitments relating to the safe use of the products, including risk minimization measures and post-authorization safety studies requested by a health authority (HA).
- Lead the APAC Safety organization and build strong networks and collaborations with safety colleagues across all sectors in the region.
- Drive the Pharma safety strategic and operational interests in the region and serve as a key interface between global functions, regional leadership and the local operating companies (LOCs).
- Ensure responsibilities outlined in the Service Level Agreements between Global Medical Safety organization and the LOCs are mutually fulfilled with respect to product safety accountabilities.
- Oversee Pharma medical safety operational and local facing area leaders in the region.
- Contribute to inspection readiness and training related to Pharma safety policies and procedures. Participate in product safety issue management with local and regional leaders and serve as a member of the Local Medical Safety (LMS) Leadership Team.
PRINCIPAL RESPONSIBILITIES: (% OF TIME)
1. Oversee Pharma product safety strategy, PV operational excellence and capability development in Asia Pacific, in partnership with LOCs, local safety officers (LSOs) and other business partners in the region. (25%)
2. Align business partners in the region including Pharma QPPV, commercial organization, medical affairs, research & development and other business partners and LSOs to develop and implement strategies and action. (25%)
3. Ensure Inspection Readiness: (10%)
- Proactively lead preparations for PV audits (internal or partner) and HA inspections. Facilitate the preparation and finalization of the response to audit/inspection observations
- Coordinate all regional safety activities including policy and procedure development, implementing and facilitating compliance with Service Level Agreements. Oversight of Asia Pacific safety staff and infrastructure
- Develop and implement comprehensive training and quality program, in collaboration with the regional and local leadership and Pharma safety partners allowing the LSOs to be inspection ready
- Collect, analyze and remediate performance metrics for the region, in collaboration with Global Medical Safety, regional and local leadership
- Conduct and maintain ongoing PV risk assessment, with a robust strategy for remediation
- Liaise with International PV Regional Heads to share best practices and knowledge
4. Raising the understanding of the strategic needs for PV in the region through: (25%)
- Regular and ad hoc communication with key stakeholders in the area
- Building knowledge platforms for PV in partnership with other regions
5. Contribute to global efforts to develop an LSO retention strategy including, career path and opportunities for recognition and participation in the global PV community. (10%)
6. Serve as a member of the Local Medical Safety Leadership Team. (5%)
Minimum Qualification
- BA in Technical, Business or Scientific Discipline required. Masters level or advanced degree in medicine, business, human relations, or 10-12 years relevant experience in pharmaceutical, business development or other global regulated industry required in lieu of Master’s degree.
- International exposure in Pharmacovigilance.
- Pharmaceutical Company or other relevant industry experience in the areas of regulatory affairs, quality, pharmacovigilance, business development and related areas required.
