Vacancy expired!
Janssen Research & Development,
LLC, a member of the Johnson & Johnson Family of Companies, is recruiting
for a Case Processing Manager located in Horsham, Raritan NJ or High Wycombe, England.In this position you will direct and
supervises the operational and management activities of a team of Drug Safety
Associates (DSAs) dedicated to processing ICSRs and performing vendor oversight
functions at a defined Case Processing Center. Liaises with staff in Global
Medical Safety Operations (GMSO) functions, Global Case Management (GCM) Case
Receipt, Sector Liaison, Global Regulatory Reporting, as appropriate to
facilitate compliant, timely and efficient end-to-end case management. The Case Processing Manager will:
Responsible for workload management, ensuring ICSR
quality standards and compliance timelines are met
Subject matter mentorship, product/process expertise
and leadership to Vendor Personnel
Monitor defined Quality Control procedures (e.g. quality
check line listings, oversight activities, etc.) to ensure timely
completion and resolution of discrepancies
Special project leadership, planning, implementation
and post project review
Provide strategic resource planning with counterparts
to lead intermittent bolus activities and identify resource needs above
defined sourcing levels to identify alternate options (e.g. supplemental
sourcing strategies)
Assign resources to ensure appropriate functioning of
team
Contribute to development and implementation of
strategic direction for case processing functions
Lead Pharmacovigilance Operational Team (PVOT) meetings
with business partners
Support internal audits and external inspections
Perform performance management activities, including
establishment and monitoring progress of team member goals and objectives,
staff development plans, and execution of those plans for direct reports
Participate in recruitment of staff
QualificationsQualifications:
RN or BS degree in health-related field,
PhD/PharmD or other related scientific degree/qualification required OR 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. Typically demonstrated by a minimum of 5
years pharma experience preferred
Extensive knowledge and experience with
safety reporting and regulatory compliance, and experience of international
safety reporting/regulations preferred
Experience in high volume work environment
preferred
Ability to allocate resources and provide
personnel management to staff
Ability to identify, hire and retain
professional staff
Previous experience in a relevant
management role is preferred, however is not essential
Strong leadership skills, ability to lead
a team
Leadership skills for planning professional
development of direct reports
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 facilitate change
Demonstrates strong Credo values
Ability to organize training activities
and train personnel on pharma safety topics
Ability to identify training needs of team
members
Excellent
verbal, written and presentation skills
Good
computer skills (Word, email) and familiarity with safety systems
Knowledge
or experience with Excel, PowerPoint, Visio preferred
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.Primary LocationUnited States-Pennsylvania-Horsham-100 Tournament DriveOther LocationsNorth America-United States-New Jersey-Raritan, Europe/Middle East/Africa-United Kingdom-England-High WycombeOrganizationJanssen Research & Development, LLC (6084)Job FunctionPharmacovigilanceRequisition ID4661190912
