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.
As the Senior Intake Operations Scientist you will be Supervising the operational and management activities of identified case receipt staff to ensure compliance with worldwide safety regulations and corporate policies. You will be monitoring of daily workload activities to maintain regulatory compliance and quality standards. Having oversight of off-shore vendors contracted to perform Case Receipt (CR) activities, supporting inspections/audits and point of contact for training activities. Act as a key contact or point of expertise for the department and external contacts for designated products or processes. You will be Liaising with staff in Global Medical Safety Operations (GMSO) functions (Global Case Management (GCM), Case Processing, Safety Reporting) and on-shore/off-shore vendors contracted to perform case receipt activities as appropriate to facilitate compliant, timely and efficient end-to-end case management.
- Facilitating / participating in workload meetings to ensure appropriate you will distribute resources, allowing the organization to dedicatedly adjust and address evolving business priorities within case receipt.
- Contributing to workload monitoring activities to ensure product specific reporting obligations (e.g. Pharmacovigilance Agreements (PVA), aggregate data locks) are managed.
- Providing vendor oversight activities for CR activities
- You will Interface and partners with partners from key internal & external organizations including Global Clinical Operations/Medical Affairs, third parties conducting clinical trial activities on behalf of Clinical, Call centers, Complaint Vigilance Organization, Local Safety Officers, J&J Legal and Business Partners to ensure accurate and timely intake of ICSRs.
- You will hold responsibility for the development, tracking, and execution of telephone follow-up program in the USA for ICSRs following company standard operating procedures, internal business practices, and regulatory guidance documents ensuring compliance with worldwide safety regulations and corporate policies.
- Supporting initiatives to improve future system capabilities, including but not limited to developing rules for system automation and oversight of automation.
- Collaborating with internal GMS personnel to develop harmonized consistent processes
- Supporting the Manager/Associate Director in internal audits and external inspections
- You will have a close liaison with case receipt team regarding department processing issues, helping to manage changes to the process and problem resolution where possible.
- Developing strategies to ensure efficiencies within all aspects of CR activities and quality process improvements are in place
- You will monitor quality of CR activities and facilitate remedial actions as needed; identify and report on trends, Assists as needed with implementation of processes and issue management
- Participating in local or global project teams, including on-time delivery of assigned responsibilities
- You will be a key representative for site inspections and audits as identified, including
- Leading the development and implementation of corrective/preventative actions relating to Case Receipt
Do you have the following Education, Experience and leadership qualities?
- Health/Biomedical Degree (Preferred)
- You are experienced in the Pharmaceutical industry with a focus on pharmaceutical safety related areas, including individual and aggregate reports. Typically demonstrated by a minimum of 5 years pharma experience
- Deep understanding and experience with single case safety management and regulatory compliance; experience with international safety reporting/regulations required
- Experience in high volume work and you have collaborated with vendors preferred
- You are a strong leader who can lead a team, cross functional projects
- Ability to coordinate and harmonize workflow activities of the team
- 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; works independently
- Ability to view the ‘big picture’ and anticipate impact of business decisions taken across the department or function
- Practical knowledge of global regulatory pharmacovigilance requirements
- Ability to prioritize, plan and organize work assignments, with ability to work under strict timelines
- Ability to organize training activities and train personnel on pharma safety topics
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United Kingdom-England-High Wycombe-
Janssen Cilag Ltd. (7360)