Global PV Operations, ICSR Management Director

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Global PV Operations, ICSR Management Director

Sector: Operations and Facilities Management
Role: Director
Contract Type: Permanent
Hours: Full Time

Site Name: Home Worker – GBR, USA – Pennsylvania – Philadelphia
Posted Date: Dec 24 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?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class (US only).

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