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Director, Safety Reporting
High Wycombe, United Kingdom
Drug & Product Safety Operations
Requisition ID: 1701644588W
Job Title: Director Safety Reporting
Business: Janssen UK
This role will close on Wednesday 27th December 2017
Who is Janssen? We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So every day, in more than 150 countries, we bring cutting-edge science and the most creative minds in the industry together to think differently about diseases. We aim not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.
We are looking at a future where the world of healthcare will be challenged by informed and empowered patients. We work for change that will improve access to medicines: the best available treatment at an affordable price. That’s why we at Janssen strive to provide access to effective and affordable medicines and related healthcare services to the people who need them.
This position is responsible for directing and supervising the operational and management activities related to electronic (E2B) or manual reporting of Individual Case Safety Reports (ICSRs) to Regulatory Authorities and/or Business Partners in accordance with Worldwide Safety Regulations, corporate and regulatory guidance documents, corporate policies, and/or third-party agreements. Also, oversight of activities related to the set up of Local Case Reporting (LCRx) queries to enable safety reporting in compliance with local regulatory requirements and/or third-party agreement requirements. Liaises with staff in Global Medical Safety Operations (GMSO) functions (Case Receipt, Case Processing, PV Evaluation, Reporting, Systems,) as appropriate to facilitate compliant, timely and efficient case processing and reporting activities. Liaise with groups external to GMSO functions regarding activities associated with safety reporting activities, including but not limited to the Medical Safety Surveillance & Insight, International Pharmacovigilance (IPV) area, Office of Consumer Medical Safety (OCMS), Medical Device (MD), Global Clinical Operations (GCO) Safety Unit, .
• Implement strategic direction for Safety Reporting Team responsible for electronic and manual reporting of ICSRs to Regulatory Authorities and/or Business Partners, accurately and timely, maintaining compliance.
• Monitor daily activities of direct reports responsible for LCRx query set up to enable electronic and manual reporting of ICSRs to Regulatory Authorities and/or Business Partners.
• Identify resource requirements for safety reporting team to ensure appropriate functioning and capacity utilization
• Develop and monitor appropriate metrics for compliance and quality
• Ensure accurate and timely completion of activities associated with delegation activities related to electronic reporting (interactions with Local Safety Officers (LSOs) or Business Partners who delegate electronic reporting to GMSO).
• Review process of local case queries.
• Escalation of issues to senior management as appropriate.
• CAPA management, lead and or provide oversight to investigations, assigned CAPAs, Task Actions, Effectiveness Checks and associated documentation ensuring documentation accuracy, compliance with completion timelines, and inspection ready state of all documentation.
• Business lead for audits and inspections regarding operational activities associated with safety reporting activities or other scope as identified
• Accountable for the development and implementation of SOPs/WIs relating to LCRx query set up and electronic reporting of safety information.
• Evaluate new, changing and emerging PV legislation for potential safety reporting impact, including required systems and procedures to ensure compliance, potential resource, process and budgetary impact.
• Overseeing performance management, staff development plans and execution of those plans.
• Recruit, select, and hire qualified and diverse workforce
• Evaluates and identifies staff training needs to ensure all personnel are adequately trained and have necessary skills to perform their role.
• Oversight of training compliance of direct reports.
• Maintain knowledge and expertise on worldwide regulations/guidance related to single case processing activities
• Leads internal Safety Reporting and GMSO teams and collaborates with external customers to develop unified consistent processes related to regulatory reporting and distribution of ICSR, and LCRx query set up.
• Actively participate in cross-functional senior leadership activities (e.g. Strategic Objective Lead, Leadership Teams)
• Provide strategic input &/or develop collaborative working relationships with J&J stakeholders/functions to clarify procedures impacting GMSO operational activities and ensure optimal efficiencies
• Overall accountability for implementation of strategies supporting sustainable service delivery
• Ability to understand and interpret regulations and reporting requirements including third party agreements and translate into queries for reporting to Regulatory Authorities resolving discrepancies and identification of viable options to resolve business challenges.
• Ability to independently make decisions and understand complexities of J&J product and Adverse Event categories in order to properly establish accurate queries. Problem solving abilities to handle E2B and LCRx issues and escalate when appropriate.
• Coordinate activities with GMSO Leadership for defining and evaluating operational strategy
• Overall accountability for defining and implementing organizational development strategies to ensure the leadership pipeline and organizational capabilities are maintained.
• Lead change management initiatives where there is the need to influence, direct, or lead change to prepare the organization for expansion, evolution in response to increased complexities associated with business
EDUCATION & EXPERIENCE REQUIREMENTS
• RN or BS degree in health related field, PhD/PharmD or other related scientific degree/qualifications is preferred.
• For nurses or pharmacists, certification / licensure is required (RN, RPh, PharmD).
• Previous industry and/or clinical experience with focus on pharmaceutical safety related areas, including individual and aggregate reports.
• Extensive knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting / regulations.
• Experience in high volume work environment is preferred.
• Experience with identifying and evaluating methods for improving efficiency, accuracy and regulatory compliance.
• Ability to allocate resources and provide personnel management to people leaders.
• Ability to identify, hire and retain professional staff.
• Ability to escalate issues as appropriate.
• Strong Leadership skills, ability to lead a functional group.
What we’re about:
We are passionate about our work, and play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. We share a kind of DNA where we’re each
• Committed to caring
• Responsible to our communities
• Ready to apply our knowledge and know-how
• Unique in our background and experiences
• The drivers of our own success
• Passionate about doing what’s right
Make a unique mark in your career
If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your passion for caring and success, then we invite you to join the Johnson & Johnson Talent Community by visiting www.careers.jnj.com
We respectively request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson Medical, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
United Kingdom-England-High Wycombe
Janssen Cilag Ltd. (7360)
Drug & Product Safety Operations