Johnson & Johnson Careers
Senior Director, Head of Global Drug Safety Operations
Requisition ID: 7706190214
Johnson & Johnson is recruiting for a Senior Director, Head of Global Drug Safety operations to be located in Cherry Hill, NJ
The Global Drug Safety Operations Team Leader is the leader of the Operations group across all Actelion Drug Safety sites (US and Switzerland), responsible for ensuring department deliverables, planning strategically for future needs, hiring and training of department personnel, and ensuring full integration of drug safety operations staff and processes within the Global Drug Safety (GDS) organization. The position oversees the production and ensures compliance of individual case reporting for Actelion Global Drug Safety (quality, procedures, regulations, timeliness, consistency). Directs and supervises the operational activities of case receipt, processing, safety reporting and systems functionality management globally including management of case processing and safety reporting personnel across all data processing sites, and provides functional oversight of case management and safety data management (PV systems) for contracted vendor organizations.
The Global Drug Safety Operations Team Leader is responsible for managing all aspects of drug safety operations across all sites, which includes:
- Processing of all adverse events in Argus for investigational and post-marketed products.
- Submissions of expedited reports to the EU, FDA & other health authorities.
- Developing standard procedures and guidelines for Global Drug Safety operations, which are integrated and fully aligned across all GDS sites.
- Developing cross-functional Pharmacovigilance procedures & ensuring proper reconciliation with other systems processing safety information.
- Effectively utilizing case metrics to assess productivity, opportunities for workflow and quality improvement, and to measure effectiveness of change initiatives.
- Fully supporting training of department personnel and other line functions involved in AE collection or processing such as Medical Affairs, marketing, medical information, etc., in collaboration with Global Drug Safety Quality System, Compliance and Training groups
- Negotiating agreements and processes with business partners, including safety data exchange agreements and Pharmacovigilance agreements.
- Vendor oversight and management for all outsourced or insourced Global Drug Safety operational activities
- Proactively ensure readiness & proper management of regulatory authority inspections.
- Act as business lead for internal audits and external inspections for operational activities, or other scope as identified.
- Oversight of safety reporting to government agencies and internal or external business partners. Includes responsibility for US and EU/ROW safety reporting to Health Authorities/ Agencies, License Partner Reporting and Clinical Safety Reporting to Investigators, Ethics Committees and Independent Review Boards.
- Deliver centralized electronic reporting in accordance with global safety regulations, corporate and regulatory guidance documents and corporate policies
- Support GDS physicians in the preparation of Periodic reports (e.g. PBRER, PADER, DSUR) & other safety documents as required.
- Develop efficient workflows in Argus in conjunction with Global Drug Safety Systems team.
- Line management of global case receipt, processing, and safety reporting personnel across all sites, with emphasis on performance management, career development, succession planning and organizational design.
- Provide leadership for a high performing team of professional and clerical staff
- Use organizational design principles to determine optimal structure to achieve business objectives.
- Proactively lead continuous case processing/ case quality improvement initiatives
- Through talent development, continuously enhance the level of performance achieved by the organization
- Recruit, select and hire a qualified and diverse workforce
- Represent Global Drug Safety on project teams, other departments, and committees as needed.
- Lead case receipt, processing and safety reporting teams, plus other cross-functional teams, to develop efficient, consistent processes designed to meet business objectives
- Participate in GDS cross-functional and GDS senior leadership activities (e.g., Strategic Objectives, Leadership Teams).
- Provide strategic input and/or develop collaborative working relationships with Actelion and JNJ stakeholders/ functions at all levels within and outside of GDS to clarify procedures impacting GDS activities and ensure optimal efficiencies. Includes collaboration with Clinical Operations, Regulatory Affairs, Information Technology, QPPV, Quality and Compliance.
- Ensure global case processing and safety reporting team personnel remain informed of changes in regulatory requirements and adopt/ adapt relevant case management processes within acceptable timeframes.
- Supervises all Global Drug Safety Operations personnel in all Global Drug Safety case processing sites (US and Switzerland).
- A Minimum of a bachelor’s Degree is required
- A Degree in medicine, Pharmacy, Nursing or equivalent is preferred
- A minimum of 8 years of experience in pharmaceutical drug safety, with minimum of 5 years of experience in drug safety operations management is required
- Knowledge and experience with currently available drug safety database systems (ARGUS, ARIS G), document management systems and QC tools is required
- Operational expertise with ARGUS preferred.
- Excellent organizational and leadership skills, and ability to work under pressure and tight timelines is required
- Thorough knowledge of domestic and international regulatory reporting requirements.
- Prior project management/ change management/ process improvement experience in matrix environment preferred.
- Experience in high volume work environment.
- Experience with multinational integration activities and multi-cultural working is preferred.
- Ability to coordinate and harmonize workflow activities across multiple centers.
- Ability to evaluate processes and procedures against outcomes to identify methods to improve efficiency, accuracy and compliance.
- Ability to utilize appropriate initiative and autonomy in achieving objectives, working independently.
- Demonstrated experience in motivating and developing management staff.
- Ability to identify, hire and retain management and professional staff.
- Ability and willingness to travel up to 30% both domestically and internationally.
United States-New Jersey-Cherry Hill-
Janssen Research & Development, LLC. (6084)