Global Pv Operations, Icsr Management Director

Site Name: Home Worker - GBR, USA - Pennsylvania - Philadelphia Posted Date: Nov 15 2024 Job Purpose The key purpose of this role is to support Pharmacovigilance Operations ICSR Management in the following activities: ICSR Management: Oversight of handling and processing of ICSRs; ensuring proper case management and following coding conventions.
Argus Configuration: Oversight of setting up Safety Database for new programs and studies, and configuring it for submissions to regulatory authorities, partners, CROs, and local operating companies (LOCs).
LOC Interactions: Collaborating with local operating companies.
Vendor Oversight: vendor oversight of case processing and related activities, ensuring compliance with GSK processes and contracted tasks.
Oversight of investigations into ICSR related non-compliance, perform gap analysis, and critically analyse data and metrics produced by the vendor.
Clinical Trial/Program Support: Involvement in study/program setup, maintenance, and close-out processes.
The position holder is responsible for the above elements in alignment with GSK standards and regulatory timelines whilst driving the implementation of robust processes for successful PV Operations activities, including vendor oversight.
Key Responsibilities Provides leadership for Individual Case Safety Reports (ICSR) Management Team to achieve group objectives, overseeing outsourcing partner who processes over 300,000 cases annually in the GSK global safety database.
Ensuring compliance with regulatory requirements, establishing, and overseeing management monitoring activities, and mitigating business risks in ICSR Management.
Delivering efficient, compliant processes and addressing deficiencies.
Ensuring preparedness and implementing corrective actions for audits/inspections.
Facilitating cross-functional collaboration within Global Safety and ensuring timely processing Human Safety Information for signal detection.
Establishing and maintaining key performance indicators for case management operations.
Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree BS/BA in a scientific or medically related field (e.g.
Nurse or pharmacist) Experience in the pharmaceutical industry/CRO in clinical development, pharmacovigilance and information management.
Previous line management experience Preferred Qualifications: If you have the following characteristics, it would be a plus: Extensive clinical safety or related experience (10+ years) Significant history of management experience Demonstrated experience effectively working with outsourced providers.
High level of clinical understanding Excellent oral and written communication skills In depth knowledge of ICH, GCP and GVP, CTR; local regulatory requirements and pharmacovigilance methodology; general understanding of world-wide regulatory requirements for PV Proven ability to negotiate and influence stakeholders at upper management levels.
Deep knowledge of principles of data collection, analysis and retrieval and experience summarizing data Knowledge of GSK products and awareness of business-unit specific considerations In depth understanding of medical and drug terminology Why GSK?
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