Full-Time
Director – Medical Evaluation & Case Processing Oversight
Posted on 5/9/2026
CSL
10,001+ employees
Develops and delivers biotherapies and vaccines
No salary listed
King of Prussia, PA, USA + 1 more
More locations: Maidenhead, UK
In Person
 Biology & Biotech (1) |
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- Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance experience with 5 years of managerial/leadership experience
- Global pharmacovigilance database knowledge is required
- Proficient knowledge of global and local regulatory rules and regulations
- BS/BA, RN, Pharmacist, or similar
- 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
CSL is a global biotechnology company that develops and delivers biotherapies and influenza vaccines. It focuses on plasma-derived and recombinant therapies for rare and serious diseases and sells to healthcare providers, hospitals, and governments across the Americas, Asia Pacific, and Europe. Its product range includes treatments for rare diseases, influenza vaccines, and antivenoms, produced through its R&D, manufacturing, and distribution operations. CSL differentiates itself by offering the broadest portfolio of plasma-derived and recombinant therapies and by leveraging its global footprint and emphasis on diversity to reach diverse markets. The company’s main goal is to save lives and protect health by expanding access to high-quality therapies and vaccines worldwide.
Company Size
10,001+
Company Stage
IPO
Headquarters
Parkville, Australia
Founded
1916
Simplify's Take
What believers are saying
- HEMGENIX gene therapy sustains 37% factor IX levels through four years post-2025 data.
- KOSTAIVE self-amplifying mRNA COVID vaccine approved by EC February 2025.
- VarmX $2.2B acquisition option expands bleeding disorder pipeline in 2026.
What critics are saying
- Seqirus separation triggers $500M charges and 14% revenue loss from Pentagon mandate scrap.
- Grifols opens 20 plasma centers by 2027, eroding CSL Behring's immunoglobulin share.
- Novartis Fabhalta displaces CSL Vifor's $1.5B nephrology revenues within 12 months.
What makes CSL unique
- CSL Behring leads plasma-derived therapies for haemophilia and immunodeficiencies.
- CSL Seqirus dominates influenza vaccines with global production scale.
- CSL Vifor specializes in iron deficiency and nephrology treatments post-2022 acquisition.
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401(k) Retirement Plan
401(k) Company Match
Paid Time Off
Paid Vacation
Paid Sick Leave
Paid Holidays
Company News
In a high-stakes move that could reshape emergency medicine, global biotech giant CSL has struck an exclusive option agreement to acquire VarmX, a Netherlands-based biotech, in a deal valued at up to $2.2 billion. The announcement, made Tuesday by EQT Life Sciences, which counts VarmX in its portfolio, underscores just how valuable the Dutch company’s CSL to acquire VarmX in a $2.2B deal, backing breakthrough bleeding drug VMX-C001 with full trial funding.
Global biotechnology leader, CSL, celebrated the Company’s 25th Anniversary of listing on the Australian Securities Exchange (ASX), commemorating the occasion with a ceremonial bell ring at...
Automated Logic – Canada, Ltd. (ALC), part of Carrier Global Corporation, has acquired Control Solutions, Ltd. (CSL), an independent provider of building-automation systems in Coquitlam, British Columbia. This acquisition establishes ALC's first field office in Vancouver, expanding its presence in Western Canada and enhancing its ability to deliver intelligent building solutions in high-growth sectors across British Columbia.
Vienna, Austria – 9 April 2025 - CSL Behring Austria today announced that the first haemophilia B patient in Austria was treated with the gene therapy HEMGENIX® (etranacogene dezaparvovec) at the Comprehensive Care Center of the University Hospital of Medicine Vienna.HEMGENIX® is the first one-time gene therapy approved in Europe for the treatment of adults with severe and moderately severe haemophilia B, an inherited bleeding disorder caused by the lack of Factor IX (a protein needed to produce blood clots to stop bleeding). It is used in adults without a history of Factor IX inhibitors.1“It is a great opportunity for people with hemophilia B to live a symptom-free life for many years,” explains hematologist Univ.-Prof. Priv.-Doz. Dr Cihan Ay from the Medical University of Vienna, University Clinic for Internal Medicine I Clinical Department for Hematology and Hemostaseology."For the community of affected patients and their families, this represents an enormously significant milestone: the ability to treat hemophilia with gene therapy, and the fact that this option is now available in Austria, is something our community has been eagerly anticipating and hoping for over decades," says Thomas Schindl, MA, Chairman of the Austrian Hemophilia Society (ÖHG)."We are proud and grateful to offer haemophilia B patients in Austria a treatment option that has the potential to transform their lives," said Dr Beate Natmessnig, Managing Director of CSL Behring Austria. "This achievement is the result of outstanding regional and national collaboration among all parties involved and is a strong testament to Austria's innovative capabilities."HEMGENIX® was granted conditional marketing authorisation by the European Commission (EC) for the European Union and European Economic Area in February 2023, following approval from the U.S. Food and Drug Administration (FDA) in November 2022
Marburg, Germany, 2 April 2025 – CSL Behring and the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds) have successfully concluded negotiations on the reimbursement price of HEMGENIX®. This agreement marks the availability of the first gene therapy approved in Europe for haemophilia B under an innovative, national, success-based reimbursement model, being implemented for the first time in Germany.HEMGENIX® represents significant progress in the treatment of haemophilia B. The aim of this one-time gene therapy is to eliminate the need for regular factor IX infusions, thereby offering patients the possibility of more freedom from prophylaxis and significantly improving their quality of life.1-4 This development not only provides substantial relief for those affected but also has the potential to reduce long-term costs for the healthcare system.‘The performance-based payment model at national level which was agreed with the GKV-Spitzenverband is unique in Germany. It addresses key reimbursement challenges, such as the question of long-term efficacy, which is inherent for any one-time therapy. Reimbursement is linked to treatment success of the individual patient,’ explains Stefan Neudoerfer, CSL Behring's chief negotiator in Germany.Moreover, this reimbursement model reflects the high therapeutic and innovative value of HEMGENIX® and sets new standards for integrating innovative gene therapies into the German healthcare system.‘The agreement on the reimbursement price of HEMGENIX® is a decisive step for the care of people with haemophilia B in Germany. It enables access to a groundbreaking therapy and recognises the long-term medical and economic benefits of gene therapy,’ explains Christian Wieszner, Managing Director of CSL Behring Germany.With this agreement, CSL Behring is underlining its commitment to innovative therapies that sustainably improve the lives of patients