Senior Specialist, ICSR Management

Key Responsibilities -

• Contribute to all aspects of case handling activities from case receipt to expedited reporting and collaborate with stakeholders (i.e., the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs) and clinical operations/sciences) to ensure that documentation and processes are in place to achieve successful recording and reporting of safety data during the life cycle of a clinical trial and marketed product.

• Work across a complex matrix environment to drive high-quality delivery of case management activities that comply with internal standards and external regulatory requirements; where problems or issues are identified, facilitate investigation into root cause and create corrective/preventative actions (CAPAs)

• Escalate identified problems or issues to the appropriate Management Personnel with PV Operations

• Generate new ideas and proposals for global implementation; contribute to advancement of PV Operations methodology and processes.

• Ensures third parties/vendors develop and implement robust processes to support quality-driven organization.

• Support Technical Associates with enhancement of knowledge and skills for ICSR Management activities

• Assist with the set-up studies/programs including the review of study documents such as protocols, contracts, Clinical Trial Applications etc.), safety slides, AE/SAE forms, and attend Kick off Meetings

• Assist ICSR Management Leads with spot checks in JIRA and other applicable repositories to ensure relevant documents have been filled appropriately.

• Assist ICSR Management Lead with the oversight of study reconciliation activities

• Escalate to the ICSR Management Lead, as needed

• Review of Safety Management Plans (SMP), Data Management Plans (DMP), Protocol Data Entry Guidelines (PDEGs) and complete start-up/close out checklists

• Prepare and submit safety database configuration requests, review User Acceptance Testing (UAT) outputs for Electronic Data Capture (EDC) and Safety Database (SDB), assist the ICSR Management Lead in vendor training

• Review and maintain oversight of training materials developed by third parties/vendors

• Monitor key performance indicators (KPIs) generated from supplier and quality organizations, determine appropriate responses to manage and mitigate risk, and identify issues for escalation/action as required.

• Maintain awareness of /CRO/licensing partner reporting rules and ensure case handling is aligned with reporting timelines and expectations; demonstrate expert working knowledge of the regulatory environment on a global level

• Manage PV Operations mailboxes for Spontaneous and Clinical Trial queries and provide timely responses to queries.

Job-Related Skills -

• Knowledge of Good Clinical Practice (GCP), Clinical Trial Regulation (CTR) and Good Pharmacovigilance Practice (GVP), clinical safety documentation, reporting of adverse events from clinical trials, local regulatory requirements, and pharmacovigilance methodology; general understanding of worldwide regulatory requirements

• Working knowledge of principles of data collection, manipulation and retrieval and experience summarizing data

• In-depth understanding of medical and drug terminology

• Proven experience of prioritisation and time management

• Strong communication skills

• In-depth knowledge of safety databases strongly preferred

Job Purpose -

ICSR Management:

• Argus Configuration for new Programs/Studies

• ICSR processing

• Case Processing Coding Conventions

• Local Operating Companies (LOC) Interactions

• Functional Vendor Oversight:

• New Market Authorisation

• Withdrawal of Market

• Authorisation

• PAC awareness

Clinical Trial/Program Interactions for:

• Study/Program Set up

• Study/ Program Maintenance

• Study/ Program Close out

Argus Configuration for Submissions to destinations including:

• Regulatory authorities

• Partners

• Clinical Research Organisations (CROs)

• LOCs

• Clinical Operations/CROs

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

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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