Manager, Case Processing

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We are searching for the best talent for our Manager Case Processing position to be located in High Wycombe United Kingdom.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-068091

United Kingdom- Requisition Number: R-070284

Switzerland - Requisition Number: R-070281

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

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The Manager Case Processing directs and oversees the operational and people management activities of a team of Drug Safety Associates (DSAs) responsible for processing investigational Clinical Trial (CT) Individual Case Safety Reports (ICSRs) including activities required to meet Serious and Unexpected Suspected Adverse Reaction (SUSAR) reporting requirements (e.g. single case unblinding analysis of similar events (AOSE)) at designated Case Processing Centers.

This role partners closely with Global Medical Safety Operations (GMSO) functionsincluding Global Case Management (GCM) Global Case Receipt Global Safety Reporting Medical Analytics & Safety Surveillance (MASS) and Pharmacovigilance Evaluation and Reporting (PVER)as well as Clinical Development organizations and thirdparty partners to enable compliant timely and efficient endtoend management of investigational CT ICSRs.

You will be responsible for:

• Directly leading the daily operational activities of a Global Case Processing team within Global Medical Safety Operations ensuring effective workload management and adherence to ICSR quality and timeline standards.
• Managing and supporting team members in daytoday case processing activities through coaching guidance performance management and ongoing staff development.
• Ensuring the quality accuracy and regulatory compliance of teamprocessed ICSRs with particular focus on SUSAR reporting requirements including completeness of case narratives coding activities AOSE and related documentation.
• Overseeing defined quality control and oversight procedures to ensure timely completion issue identification and resolution of discrepancies.
• Performing peoplemanagement responsibilities including goal setting performance evaluations development planning participation in recruitment identification of training needs and oversight of training compliance for direct reports.
• Leading resource planning and allocation activities to support routine operations and evolving clinical program needs ensuring appropriate staffing to maintain operational continuity and compliance.
• Monitoring clinical program activities and trends that may impact case management operations and proactively adjusting resources and plans as needed.
• Providing strategic resource planning in partnership with crossfunctional counterparts to manage intermittent or surge activities (e.g. SAE reconciliation interim and endofstudy unblinding) including escalation of resourcing needs beyond defined sourcing models and identification of alternate solutions.
• Serving as a subjectmatter expert in clinical trial case processing and contributing to the development and execution of strategic objectives for Global Case Processing.
• Partnering with MASS and Medical Safety Officers (MSOs) to address GCO ICSRrelated inquiries; participating in Safety Management Team (SMT) and Pharmacovigilance Operational Team (PVOT) meetings; and ensuring team awareness of case processing obligations and timelines associated with Clinical Trial Agreements (CTAs) Pharmacovigilance Agreements (PVAs) and Collaboration Agreements (CAs).
• Supporting and deputizing for the Associate Director or Director Global Case Processing as required including participation in internal audits external regulatory inspections and other leadership initiatives.
• Maintaining compliance with company guidelines pharmacovigilance regulations and HR policies and performing other related duties as assigned.

Qualifications/ Requirements:

• Bachelors degree in a healthrelated or scientific discipline (e.g. Nursing Pharmacy Life Sciences) is required. An advanced degree (PhD PharmD) is preferred.
• For nurses or pharmacists active professional licensure/certification (e.g. RN RPh PharmD) is required.
• Minimum of 5 years of pharmaceutical industry or clinical experience with a focus on pharmacovigilance and drug safety including individual and aggregate safety reporting is required.
• Demonstrated knowledge of global safety reporting regulations and regulatory compliance across the product lifecycle (investigational and postmarketing environments).
• Experience working in a highvolume regulated operational environment preferred.
• Demonstrated peoplemanagement capability including resource allocation performance management hiring onboarding staff development and training within a regulated pharmaceutical setting.
• Ability to plan coordinate and harmonize team workflows to meet quality compliance and timeline expectations.
• Experience evaluating processes and implementing improvements to enhance efficiency accuracy and compliance.
• Strong leadership skills with the ability to motivate teams manage change and operate with appropriate autonomy and initiative.
• Demonstrated commitment to Credobased values and ethical decisionmaking.
• Knowledge of the legislative and regulatory context governing pharmacovigilance activities.
• Excellent verbal written and presentation skills with the ability to communicate effectively across functions and levels.
• Proficiency with standard office applications (Word email); familiarity with pharmacovigilance safety systems required.
• Working knowledge of Excel PowerPoint and processmapping tools (e.g. Visio) preferred.

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