HireDiversity

Horsham, PA, US

Manager, Global Safety Reporting-1947121204

Description

Janssen Pharmaceutical Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Manager, Global Safety Reporting. This position can be based in Horsham, PA, Morris Plains, NJ or High Wycombe, UK.

Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Manager, Global Safety Reporting is responsible for the oversight and management of activities related to Business Partners, internal partners (i.e. GCO), and vendors. Activities include maintaining local case reporting queries that enable compliance and electronic or manual reporting of individual case safety reports (ICSRs) to business partners and internal partners in accordance with worldwide safety regulations, corporate and regulatory guidance documents and corporate policies. The position will also complete other relevant tasks and special assignments as required

The Manager Global Safety Reporting is responsible for the management of daily activities related to Business partners. This includes the following: manage integration and operational alignment within Global Safety Reporting (GSR); oversight of local case reporting query setup and maintenance required for ICSR distribution to business partners; GSR liaison with PAC and representative in the PVA review process, and provide input/comments; GSR liaison with business partners and representative in SOWG meetings; oversight of compliance to ensure accurate and timely electronic and manual distribution of ICSRs to business partners; manage issue escalation, CAPA, event, deviation activities associated with ICSR distribution to business partners; monitor volume, workload and trending metrics associated with ICSR distribution to business partners; and provide support for business partner audits.

This position will also have responsibility for the management of vendor related activities: GSR liaison with vendor regarding activities associated with reporting rule creation and maintenance and providing support for business partner audits and Aegis Project audits. Additionally, the Manager, Global Safety Reporting will have responsibility for the management of internal partner activities: serve as point of contact for the Global Clinical Operations Safety Unit (GCOSU) and Global Regulatory Affairs (GRA); provide support to GCOSU and GRA relative to local case reporting rule creation and maintenance, special commitments and related activities; provide training, guidance, and collaboration as required; act as SME for reporting rule creation and maintenance; collaborate with internal Global Medical Safety personnel and external customers to develop unified consistent processes and identify process improvements associated with ICSR distribution and any related activities (i.e. reconciliation) to business partners; accountable for the development and implementation of controlled documents associated with ICSR distribution to business partners; support Director/Sr. Director in internal audits and external inspections; and maintain compliance with company guidelines and HR policies.

The Manager, Global Safety Reporting will also have the following training and development responsibilities: maintain knowledge of department policies and procedures; complete development activities as applicable; and maintain knowledge on worldwide regulations/guidance related to single case processing activities.

Qualifications


A minimum of an RN or BS degree in a health related field is required for this position. PhD/PharmD or other related advanced degree/qualification is preferred. For nurses and pharmacists, certification/licensure is required (E.g. RN, RPh, PharmD).

Previous industry and/or clinical experience with a focus on pharmaceutical safety related areas, including individual and aggregate reports is highly preferred. A minimum of 3 years of pharmaceutical people, program or project management experience is required, preferably in a drug safety/pharmacovigilance related area.

Experience with identifying and evaluating methods for improving efficiency, accuracy and regulatory compliance is required. Extensive knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations is highly preferred, as is experience working in a high volume work environment.

The following skills/experiences are all preferred: the ability to allocate resources and provide personnel management to staff; the ability to identify, hire and retain professional staff; strong leadership skills and the ability to effectively lead a team; the ability to escalate issues as appropriate and the ability to evaluate processes and procedures against outcomes to identify methods to improve efficiency, accuracy and compliance.

Strong work management skills are required for this role. This includes the following: the ability to prioritize workload (ability to multi-task); the ability to coordinate and harmonize workflow activities of the team; the ability to utilize appropriate initiative and autonomy in achieving objectives; and the ability to work independently. Additional skills that are required and essential for success include: the ability to facilitate change; the ability to obtain consensus between different organizations/parts of organizations so regulations and guidelines are met by process; the ability to communicate changes effectively; and demonstrated strong Credo values.

Candidates should possess the ability to organize training activities and train personnel on pharmaceutical safety or document management topics and the ability to identify training needs of team members.

Excellent verbal, written and presentation skills is essential for success, as is solid computer skills (MS Word, Excel, Outlook, PowerPoint), Visio experience is preferred. Familiarity with safety systems is also required, with knowledge of safety databases preferred.

BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Pennsylvania-Horsham
Other Locations:Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-New Jersey-Morris Plains
Organization: Janssen Research & Development, LLC. (6084)