At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Based in our Horsham office, the Global Safety Reporting Manager within Global Case Management is responsible for directing and supervising the operational and management activities related to setting up and maintaining distribution rules and performing submissions that enable compliance with Regulatory Authority requirements.
This includes electronic or manual reporting of Individual Case Safety Reports (ICSRs) to Regulatory Authorities (RAs) and Business Partners in accordance with Worldwide Safety Regulations, corporate and regulatory guidance documents and corporate policies. The position will also complete other relevant tasks of special assignments as required.
Your Direct responsibilities will be:
- Provides direction to direct reports responsible for distribution rule set-up and accurate and timely electronic and manual ICSR reporting to RAs and Business Partners
- Builds a global team approach through collaboration with key stakeholders including UK based counterparts as well as Clinical Operations, Global Regulatory Affairs and Local Safety Officers.
- Oversees delegated electronic reporting activities (interactions with Local Safety Officers (LSO) or business partners who delegate electronic reporting to the Safety Reporting team.
- Takes responsibility for review of the distribution rule processes, reporting and resolving issues
- Ensuring quality is built into the team processes
- Takes the lead on any quality issues, CAPA management, regulatory compliance and controlled document updates.
- Provides guidance and support in relation to Health Authority Inspections and audit requests.
- Review of processes and technology to achieve continuous improvement, introducing innovation
- Hold regular 121 with staff and coach and mentor
- Identifying resource needs and allocations to ensure appropriate functioning of group.
- Overseeing performance management, staff development plans and execution of those plans
- Evaluating and identifies staff training needs to ensure all personnel have necessary skills to perform their role.
- Maintaining your knowledge of department policies and procedures and n worldwide regulations/guidance related to single case processing activities
Do you have these decision-making and analytical skills?
You will be managing the day to day operations of the Safety Reporting Group to ensure timely and accurate submissions of ICSRs to Regulatory Authorities (RA). You will understand and be interpreting regulations and reporting requirements including third party agreements, translating into distribution rules for reporting to RA. You can independently make decisions and understand complexities of J&J products and Adverse Event categories in order to properly establish accurate rules. Problem solving abilities to handle E2b and submission related issues and report when appropriate.
- Bachelor’s degree in health-related field or life sciences, PhD/PharmD or other related scientific degree/qualification is preferred
- Previous pharma industry experience with a focus on pharmacovigilance required
- Deep understanding and experience with safety reporting and compliance, and experience of USA and EU and international safety reporting/regulation required
- Experience working in high performing global teams preferred
- Experience with identifying and evaluating methods for improving efficiency, accuracy and regulatory compliance preferred
- Excellent resource allocation and staff management skills preferred
- Leadership skills for planning professional development of your direct reports preferred
- Ability to evaluate processes and procedures against outcomes to identify methods to improve accuracy and compliance pre.
- Ability to utilize appropriate initiative and autonomy in achieving objectives; works independently required
- Ability to organize training activities and train personnel on pharma safety or document management topics preferred
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Janssen Research & Development, LLC (6084)