What are the responsibilities and job description for the Director, Medical Evaluation & Case Processing Oversight position at BioSpace?
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
You will oversees all areas of single case processing in the global pharmacovigilance database from all sources. This includes ensuring that the vendor performs case processing in accordance with regulatory guidelines, PV agreements, and the Company's SOPs, as well as responding to specific questions or queries about cases. This role develops standards and processes, with a focus on global compliance and process optimization.
Oversees Medical Evaluators responsible for medical review of ICSRs.
Key Responsibilities
Oversight of Case Management Processes activities
Oversight of Medical Evaluator role which completes medical review of the following ICSRs:
All serious cases from all sources
Non-serious Cases From Company-sponsored Clinical Study, If Required
Legal ICSRs (serious and non-serious)
Reportable cases of combination products with device issue(s) / malfunction (serious and non-serious)
Non-serious ICSRs are processed by Case Managers and reviewed for correct seriousness on an aggregate basis by Medical Evaluator
Medical Review Includes
Review of seriousness, listedness and causality assessments
Review of event terms and MedDRA coding
Review of narrative for medical accuracy and consistency
Assessment of the need for Quality Investigations
Generation of medical follow up queries / Targeted Questionnaires
Drive department-wide planning: resource, budget, and org. strategy
Own case management dashboards and governance scorecards
Prepare for internal and external inspections including coordination of creation of presentations
Lead transformation initiatives (e.g., vendor transitions, digital tools)
Monitor regulatory trends and represent PV case management in global initiatives
Coordinate departmental leadership meetings and communication
Pilot innovations (e.g., RPA, AI triage, tech integration)
Align with Clinical, QA, Regulatory, and Safety Science functions
Coordinate creation and update of SOPs
Retain product and process knowledge
Skills And Education Required
Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience with 5 years of managerial/leadership experience
Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations
Qualifications And Education Required
BS/BA, RN, Pharmacist, or similar
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
You will oversees all areas of single case processing in the global pharmacovigilance database from all sources. This includes ensuring that the vendor performs case processing in accordance with regulatory guidelines, PV agreements, and the Company's SOPs, as well as responding to specific questions or queries about cases. This role develops standards and processes, with a focus on global compliance and process optimization.
Oversees Medical Evaluators responsible for medical review of ICSRs.
Key Responsibilities
Oversight of Case Management Processes activities
Oversight of Medical Evaluator role which completes medical review of the following ICSRs:
All serious cases from all sources
Non-serious Cases From Company-sponsored Clinical Study, If Required
Legal ICSRs (serious and non-serious)
Reportable cases of combination products with device issue(s) / malfunction (serious and non-serious)
Non-serious ICSRs are processed by Case Managers and reviewed for correct seriousness on an aggregate basis by Medical Evaluator
Medical Review Includes
Review of seriousness, listedness and causality assessments
Review of event terms and MedDRA coding
Review of narrative for medical accuracy and consistency
Assessment of the need for Quality Investigations
Generation of medical follow up queries / Targeted Questionnaires
Drive department-wide planning: resource, budget, and org. strategy
Own case management dashboards and governance scorecards
Prepare for internal and external inspections including coordination of creation of presentations
Lead transformation initiatives (e.g., vendor transitions, digital tools)
Monitor regulatory trends and represent PV case management in global initiatives
Coordinate departmental leadership meetings and communication
Pilot innovations (e.g., RPA, AI triage, tech integration)
Align with Clinical, QA, Regulatory, and Safety Science functions
Coordinate creation and update of SOPs
Retain product and process knowledge
Skills And Education Required
Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience with 5 years of managerial/leadership experience
Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations
Qualifications And Education Required
BS/BA, RN, Pharmacist, or similar
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.