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Senior Clinical Trial Case Manager
CSLSenior Clinical Trial Case Manager at CSL Behring handling safety data evaluations and regulatory compliance. Leading cross-functional teams in pharmacovigilance and supporting inspection readiness processes.
About the role
Key responsibilities & impact- 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 to 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 area of responsibility.
- Ensures direct reports to support and ensure QPPV’s oversight on the company’s Pharmacovigilance system, and identify, implement and monitor KPIs/KQIs across the company and manages 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. This may involve cross-functional approaches, including multiple interface functions.
- Supports the preparation and conduct of PV and other GxP inspections and audits, as required and organize 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 supervise pharmacovigilance procedures as well as processes and ensures the uniform and timely processing and analysis of safety data to comply with regulatory requirements.
- Ensure correct coding of all event and drug terms.
- Ensure inter- and intra-consistency for case evaluations.
- Participate 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.
- Develop and provide 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.
- Analyzes 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 fulfill 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.
Requirements
What you’ll need- 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. Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Benefits
Comp & perks- For more information on CSL benefits visit How CSL Supports Your Well-being | CSL
ATS Keywords
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Hard Skills & Tools
PharmacovigilanceGxP regulationsICSR reportingKPI monitoringSAE codingData analysisCAPA managementSOP developmentRegulatory complianceImpact assessment
Soft Skills
MentoringCross-functional collaborationCommunicationLeadershipOrganizational skillsAnalytical thinkingProblem-solvingAttention to detailStrategic directionLiaison skills
Certifications
Bachelor's degree in life sciencesMaster's degree in life sciencesPhD in life sciencesPharmacovigilance certification