Johnson & Johnson Careers
[Janssen] - Local Safety Officer(Long-Term Contractor)
Requisition ID: 1805692252W
Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
- Fulfil the responsibility for the coordination and execution of all Pharmacovigilance (PV) activities across the Pharmaceutical and Consumer sector to ensure that all of Johnson & Johnson’s statutory and ethical responsibilities are met. Act as the Local Operating Company (LOC)’s and assigned territories’ (as applicable) main contact point for PV matters with the local Health Authority, Global Medical Organization (GMO), Global Medical Safety (GMS) and Office of Consumer Medical Safety (OCMS). Provide strategic leadership and support LOC to meet all global and local PV responsibilities.
PRINCIPAL RESPONSIBILITIES(Include but not limited to)
- Ensure local compliance with PV requirements in accordance with local regulations and/or Johnson & Johnson procedures;
- Oversight of the full cross sector product portfolio, and link with local management and key stakeholders
- Facilitate regional and local compliance with PV obligations through active engagement and support of business partners or distributors and suppliers, in line with specific Johnson & Johnson agreements or procedures;
- Actively monitor local/regional operating performance and AE reporting compliance
- and address any shortcomings;
- Maintain up to date knowledge of and compliance with local safety regulations for country or countries under responsibility ensuring changes are communicated to GMS/OCMS;
- Provide high quality and consistent input to development of local safety initiatives and programs.
- Maintain an environment of continuous improvement within the PV team and contribute to continuous improvement initiatives across the region and globally with GMO, GMS and OCMS.
- Ensure training on adverse reporting obligations is available for local staff and others required by national practice or Company policy, including business partners or distributors and suppliers;
- Ensure local processes and procedures are in place to clearly define PV responsibilities within the affiliate in line with global SOPs and local regulations.
- Ensure that local processes, strategies and initiatives are aligned with Johnson & Johnson safety requirements;
- Lead the audit / inspection preparations for internal PV audits, Johnson & Johnson Regulatory Compliance (JJRC) and Bioresearch, Quality & Compliance (BRQC) inspections.
- Ensure inspection readiness of local safety function and serve as contact point for regional safety inspections and audits;
- Advocate and actively support PV/safety compliance;
Personal data provided by job applicants will be used for recruitment purpose only.Candidates who are not being invited for interviews within four weeks may consider their applications unsuccessful. All applications will be kept for maximum of six months as future reference for similar openings.
EDUCATION & EXPERIENCE REQUIREMENTS
- Medical, pharmacy or life-sciences degree (or equivalent)
- 2-3 years of experience in PV essential; experience working in the pharmaceutical industry is strongly preferred
- Extensive experience in conducting training
- Knowledge of PV regulations
- Experience using global safety database desirable
- Demonstrated attention to detail
- Excellent written and spoken communication and presentation skills
- Effective decision maker with the ability to assess impact of actions taken locally on the global PV system
- Fluency in written and oral English to facilitate communications with GMO, regional Medical, other global functions, and Health Authority
- High customer orientation
- Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
- Sound judgment, strong planning and organizational skills, and the ability to get things done
- Demonstrated strong sense of urgency
- Strong influencing skills with the ability to explain and defend a position which is in the best interests of patient safety
China-Hong Kong S.A.R.-Mongkok-
Johnson & Johnson (Hong Kong) Ltd. (8060)