J&J Family of Companies Cross Sector Asia Pacific International Pharmacovigilance Manager in Singapore, Singapore
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 & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
Supports the AP Cross Sector Regional Safety Team in all relevant matters related to the vigilance of the J&J product portfolio under the umbrella of International Pharmacovigilance (IPV).
Ensures a consistent compliance approach across the region in alignment with the Global Medical Safety (GMS), Global Medical Organization (GMO) and Office of Consumer Medical Safety (OCMS) processes.
Enables improvement of compliance, consistency and overall inspection readiness across AP LOCs by providing competent advice and support to employees of the Local Safety Units via the Area Safety Leads/ Country Safety Team Leads/ Country Safety Leads/ Local Safety Associates.
Supports regional process improvement projects with the objective to improve compliance, efficiency and quality. This includes investigation of compliance / quality issues to ensure that appropriate preventative/corrective actions are carried out.
Prepares or contributes to the compliance oversight reports needed for the different internal and external stakeholders
Ensures a high quality, regular review and updating AP Procedural Documents and appropriate sign-off, distribution and management thereof.
Works in a multi-disciplinary team to ensure that any Procedural Documents are in line with company policies & procedures and applicable laws & regulations and are being applied effectively both regionally and locally.
IPV Quality System
• Contributing to the development of an integrated IPV quality system:
AP: Coordinating the review and the implementation of quality documents to meet global standards and local applicable laws.
Providing quality system related support to AP LOCs
Support the implementation of quality IT systems and recommend improvements based on experience and PV needs
• Ensuring that company procedures as well as external guidelines and regulations are implemented across the AP region and adhered to Compliance
Audit and inspection readiness
In partnership with the AP Area Safety Leads/ Country Safety Team Leads
• Support the AP LOCs in building and maintaining inspection readiness for all IPV related activities.
• Provide support during preparation and conduct of Health Authority Inspections or
Audits as required.
• Review of audit and inspection reports
• Developing a Corrective and Preventive Action (CAPA) monitoring system
Tracking and trending the different observations that relate to audits and inspections conducted within AP IPV
Monitoring and follow-up on CAPAs, escalating non-adherence Regulatory requirements
• As member of the AP IPV Team, support and lead regional IPV projects.
• Work with the Area Safety leads, Country Safety Team Leads, Country Safety
Leads and the Local Safety Associates to maintain oversight of changes in AP regulatory compliance regulations and ensure appropriate dissemination and adoption of new and amended medical compliance responsibilities, and responsibilities related to J&J standards at the regional and local levels.
• Analyse and document PV compliance processes translating new/revised requirements into new or amended processes.
• Contribute to the development of a quality monitoring system to assess compliance
Tracking the different Key Performance Indicators identified to measure compliance
Escalate alert signals of non-compliance
• Monitor and review the documentation, follow-up and trending of non-compliance in reporting of single cases and aggregate reports.
• Provide input into the KPIs Metrics developed by IPV for review by IPV leadership
• Prepares the compliance oversight reports needed for the different stakeholders for final review by the AP Cross Sector Safety Leadership Team e.g. the Monthly QPPV compliance report
• Communicating to senior management continuous improvement initiatives based on quality and compliance KPIs
• Ensure timely delivery of the requested Pharmacovigilance System Master File (PSMF) annexes
• Ensure that Cosmetovigilance line listings are forwarded to LSO
• Provide LSO support for assessing reportability of Cosmetic SUEs (Serious Undesirable Effect)
• Provide LSO support for reportable SUEs
• Provide support in composition and maintenance of IPV Curricula
• Provide support in roll-out of new/revised role profiles and competency model
• Support regional training sessions for AP IPV team and employees of the Local
IPV Quality System
• Review and advice for Single Case and Aggregate Report Timeline Deviation Memo (SCTDM and ARTDM) management
• Providing support in audit preparation delivering oversight documentation SCTDM and ARTDMs
• Trend Analysis of PV Audit findings in AP LOCs
• Trend Analysis on root cause analysis of SCTDMs and ARTDMs
• Contribution to local regulatory requirements impact evaluation
• Providing ad hoc support on various questions related to Learning Management Systems and training curricula, as well as location of latest Procedural documents
EDUCATION & EXPERIENCE REQUIREMENTS
University degree in a biomedical science, health care and/or proven equivalent experience in pharmacovigilance and quality management systems.
Minimum of 3 years experience in the pharmaceutical industry, with at least 2 years experience in a position of responsibility within Pharmacovigilance and preferably 2 years in Quality Assurance and/or Procedural Document Development. Ideally 3-5 years of related experience.
Broad experience in using Quality Management systems.
Expertise in developing, managing, reviewing, implementing and maintaining procedural documents (e.g. SOPs, WI, Quality Manual, etc)
Ability to translate new requirements into new or amended process proposals.
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 Pharmacovigilance systems and processes; knowledge of or experience with International PV and compliance regulations and guidelines is an advantage for this role.
Comprehensive knowledge of Global and Local SOPs, and database systems.
Demonstrable insight to the development of regulatory requirements with knowledge of Global aspects of drug safety, including International AE reporting requirements and relevant country-specific variations within AP.
Process design and documentation skills
Analytical, and process minded with a systematic and orderly approach.
Excellent computer-based application skills, with proficiency in Microsoft Word, Microsoft PowerPoint, Microsoft Visio and other tools required to develop process documentation and training materials.
Ability to connect in a complex and geographically widespread organization.
Proven ability to maintain strong open relationships both within an organization and with external authorities.
Excellent social, organizational, oral and written communication & presentation skills and fluency in English.
Efficient, flexible and dynamic team player.
Johnson & Johnson Pte. Ltd. (8435)