Senior Clinical Trial Case Manager in Maidenhead

Responsibilities:

• Leads or plays a key role in cross-functional teams for the review of safety data or safety-related reports.
• Mentors and trains newer members of the functional area.
• Ensures functions comply with national and international regulations, such as GxP guidelines and/or any other relevant international and national legislation(s), regulations(s), and guidance(s) as well as company policies and procedures in the area of responsibility.
• Ensures direct reports support and ensure QPPV’s oversight on the company’s Pharmacovigilance system, and identify, implement and monitor KPIs/KQIs across the company and manage cross-functional CAPAs and other improvement activities on behalf of the QPPV.
• Performs impact assessment of evolving pharmacovigilance legislations and propose or provide strategic direction for implementation of required changes to the global PV system.
• Supports the preparation and conduct of PV and other GxP inspections and audits, as required, and organise or support the back-office for regulatory PV inspections.
• Maintain/contribute to regulatory required documents such as the PSMF, in line with international and national regulations, guidelines and internal standards.
• Implements and supervises pharmacovigilance procedures as well as processes and ensures the uniform and timely processing and analysis of safety data to comply with regulatory requirements.
• Ensures correct coding of all event and drug terms.
• Ensures inter- and intra-consistency for case evaluations.
• Participates in ICSR reporting compliance analysis and respective CAPA.
• Together with Risk Management function develops and maintains Medical Concepts to support internal decision making and safety analyses for safety surveillance and provides expertise to pharmacovigilance and clinical development programs with regards to safety data/SAE coding.
• Manages regular MedDRA upgrades and provides impact analysis to RM physicians and ME.
• Develops and provides advanced analytical outputs to global teams to support analyses and decision making based on safety data.
• Development of new or enhancement of existing standard reports per company BT quality standards.
• Gathers, details, and documents user requirements in a way that is useful and meaningful to their business area experts and the technical team implementing the solution.
• Analyses impact from changes to the database or change in user/reporting requirements.
• Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
• Assists in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications, product labeling/package inserts and other reports as necessary.
• May support/contribute to cross-functional BT projects to fulfil GxP requirements and to improve inspection readiness.
• May support risk management operations, including ongoing review of literature and compilation and interpretation of safety data to support product strategies.

Qualifications:

• Bachelor degree or equivalent in a life science discipline (e.g. nursing, biological, or pharmaceutical sciences), Medical Documentation, Master’s or PhD in life sciences.
• 7+ years' Pharmacovigilance experience in multinational pharmaceutical industry.
• Expert knowledge of local/international regulations and PV processes.
• Knowledge of local/international relevant GxP regulations, IT standards and other relevant legislations such as legislations related to privacy protection.
• Experience with regulatory inspections.
• Experience in administration of complex data sets.
• Experience in project-managing CAPA and SOP development.
• Experience with relevant software applications.
• Experience with GxP.

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. 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 the company accessibility statement.