Job Title: Case Management – Senior Manager Duration: 12 months with possible extension Location: Fully remote
Organization Global Patient Safety
Group Purpose •Act as US/EU local safety office and FDA/EMA point of contact for safety reporting •Submission of all individual case safety reports to FDA/EMA, business partners (license partners) and vendors •Support interactions with, business partners (license partners) and vendors for all case intake and processing activities •Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures •Ensure vendor compliance with approved processes and training requirements •Audit & external inspection support
Job Summary Responsible for: •Line Management of Case Management staff •Management of all ICSR processing globally for clinical trial and post-market cases by all case processing teams •Ensure Vendor delivers high quality cases in a timely manner to meet all worldwide regulatory authority requirements •Provide vendors with resources and training to perform their role •Analysis and communication of case QC results •Management of business partner relationships for case management •Accountable for contract wording for case related data exchange •Escalation of case related issues •Providing subject matter expertise in the interpretation of regulations as it relates to case intake and processing •Providing audit/inspection support for case management related activities •Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness •Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility •Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
Key Activities •Day-to-day issue management and oversight for Case Corrections Tracker •Ensure oversight and monthly measurement of Quality Control and Retrospective QA metrics •Oversee performance monitoring and relay quality metrics to vendors •Analysis of QC trends including actions/recommendations •Generate, communicate, and archive report of QC findings Serve as subject matter expert for case management Next Generation/automation initiative. •Provide subject matter expertise in the interpretation of regulations as related to case processing. •Audit/inspection response subject matter expert for case related findings •Ensure audit CAPAs and other actions/recommendations for ICSR processing, quality related measures and compliance issues are completed •Actively participate and support audits/inspections
Knowledge and Skills •Proficiency in global regulatory requirements for pharmacovigilance •Extensive people management experience •Expertise in all aspects of case management •Experience in managing business partner relationships •Experience in managing/supporting inspections •Presentation and communication skills •Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook
Education & Experience (Basic) Doctorate degree and 4 years of directly related experience OR Master’s degree and 8 years of directly related experience OR Bachelor’s degree and 10 years of directly related experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Top 3 Must Have Skill Sets: •Proficiency in global regulatory requirements for pharmacovigilance •Extensive people management experience •Expertise in all aspects of case management •Experience in managing business partner relationships •Experience in managing/supporting inspections •Presentation and communication skills •Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook
Day to Day Responsibilities: •Line Management of Case Management staff •Management of all ICSR processing globally for clinical trial and post-market cases by all case processing teams •Ensure Vendor delivers high quality cases in a timely manner to meet all worldwide regulatory authority requirements •Provide vendors with resources and training to perform their role •Analysis and communication of case QC results •Management of business partner relationships for case management •Accountable for contract wording for case related data exchange •Escalation of case related issues •Providing subject matter expertise in the interpretation of regulations as it relates to case intake and processing •Providing audit/inspection support for case management related activities •Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness •Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility •Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
Key Activities: •Day-to-day issue management and oversight for Case Corrections Tracker •Ensure oversight and monthly measurement of Quality Control and Retrospective QA metrics •Oversee performance monitoring and relay quality metrics to vendors •Analysis of QC trends including actions/recommendations •Generate, communicate, and archive report of QC findings Serve as subject matter expert for case management Next Generation/automation initiative. •Provide subject matter expertise in the interpretation of regulations as related to case processing. •Audit/inspection response subject matter expert for case related findings •Ensure audit CAPAs and other actions/recommendations for ICSR processing, quality related measures and compliance issues are completed •Actively participate and support audits/inspections
Possible Extension: Yes Red Flags: Please review above Interview Process: WebEx
Below is the brief introduction of SPECTRAFORCE, the benefits we offer and the disclaimers: Established in 2004, SPECTRAFORCE is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams.
We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 130 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation.
SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people (and clients) can reach their highest potential. Our entire workflow and teams are trained to cultivate the joy of NEWJOBPHORIA® with candidates and employees throughout their engagement with SPECTRAFORCE. http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, and hospital indemnity insurances. Additional benefits SPECTRAFORCE offers to the eligible employees include commuter benefits, 401K plan with matching and a referral bonus program. SPECTRAFORCE offers unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.
Note: The Company is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAhr@spectraforce.com.
