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Primary responsibility The International Pharmacovigilance (IPV) Case Management Senior Specialist is to

▪ Ensuring Individual Case Safety Report (ICSR) case processing and related activities are carried out to enable compliance with applicable regulatory requirements, company procedures, at a local/regional level or global level, and in compliance with provisions of PV agreements with business partners.

▪ The scope of support is primarily focused on countries. The role holder may be expected to support and ensure case management and related activities for other countries within the Region (centralized case management) are carried out in a timely manner.

PRINCIPAL RESPONSIBIITIES:

As applicable, the responsibilities described below may account for cross-country collaborations. INBOUND & OUTBOUND ICSR CASE MANAGEMENT Handle the following tasks, independently and with minimal supervision; ▪ Receipt, assessment and processing of incoming safety information from multiple sources, both internal and external to the Company.

▪ Enter relevant/required safety data into the Global Inbound Receipt System (GIRS) from spontaneous, clinical trials and other solicited sources.

▪ Provision of safety information/acknowledgements to marketing partners/other third-party partners/Global Medical Safety within the internal and contractual timelines.

▪ Data entry for complex cases

▪ Performing follow-up for requesting additional information from multiple sources.

▪ Assist in the quality review of data captured in the GIRS as applicable

▪ Verify and ensure translation of safety information, if applicable.

▪ Continual monitoring, assessing the reportability of ICSRs due for regulatory reporting, and submitting to respective Competent Authorities (CAs) / Business Partners (BPs), as applicable.

▪ Enable mechanisms to support LSO oversight for case management activities as applicable. e.g. escalation non-conformance in a timely manner.

▪ Liaise with applicable stakeholder to support case processing requirements for Medical device vigilance, pharmacovigilance, or cosmetovigilance (as applicable).

COMPLIANCE MONITORING

Handle the following tasks, independently and with minimal supervision;

▪ Ensure accurate and timely documentation of deviations to process/timelines, including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs) as applicable.

▪ Support LSO in review of new/revised PV regulations, evaluation of the impact on local processes and notification of appropriate global and regional

AUDIT / INSPECTION PREPARATION AND SUPPORT

▪ Represent IPV Case management or support the LSO, in matters pertaining to audit or inspection preparation or conduct.

OTHER ACTIVITIES

Handle the following tasks, independently and with minimal supervision;

▪ Ensure and support other case management related activities such as: o Vendor training, on-going vendor support on a case level (daily or as required), case review, and vendor oversight (daily or as required) o Local literature screening for ICSRs and potential safety signals (in consultation with local medical safety as needed).

Periodic reconciliation activities o Support IPV Case Management Team Lead / LSO in responding to ad hoc requests (e.g. regulatory authority requests) as required.

Lead or support case management related innovation roll-out, in collaboration with the IPV Case Management Regional and Team leads o Lead or support the coordination and process standardization efforts to cross-country collaboration with regards to case management activities, as applicable

Write or review ICSR related procedural documents and local memo implementation as applicable. o Act as a mentor to junior staff and quality checking their work o Lead or support critical project works

DECISION-MAKING AND PROBLEM-SOLVING:

▪ Collaborate with other IPV Case Management Specialists/Coordinators, IPV Case Management Team Leads, IPV Case Management Regional Lead, case processing SMEs in GMS/OCMS, local medical safety medical team and IPV Affairs, in addressing internal and external ICSR related queries.

▪ Advise the IPV Case Management Team Lead in making IPV case management related decisions of a local, regional or global impact as applicable. WORKING RELATIONSHIPS/INTERFACES: The IPV Case Management Sr Specialist will collaborate with other IPV Case Management Specialists/ Coordinators, Team Leads and across organizations and functions on matters pertaining to case management in different areas. This includes but may not be limited to the below:

▪ GMSO/ on case management related processes.

▪ CSA representatives on ICSR compliance.

▪ Safety science and policy on regulatory requirements and impact assessments.

▪ IPV (e.g. IPV Affairs, Local Medical Safety) on interfaces to case management activities and training.

▪ Local Business Quality, Regulatory Affairs, Medical Affairs functions ▪ Global Clinical Operations ▪ Local Operating Company personnel

EDUCATION & EXPERIENCE REQUIREMENTS:.

Academic qualification ▪ Strong medical background (A degree in life, health or pharmaceutical sciences is preferred e.g. Pharmacist, Medical doctor, Biologist). Essential knowledge & skills ▪ Sound knowledge of general medicine, or pharmacy, or clinical practice; proficiency in Medical terminology (local languages). ▪ Familiarity with global ICSR related global, regional and local PV procedural documents as applicable. ▪ Computer literate with expert knowledge of the Intake (GIRS) and/or expedited reporting (OST) module(s) ▪ Ability to prioritize and work to strict timelines daily ▪ Excellent verbal and written communication skills ▪ Fluency in local (if applicable) and English language required ▪ Ability to negotiate and communicate with internal and external customers ▪ Knowledge and understanding of key legislation applicable to pharmacovigilance Experience ▪ Proven expertise and experience in pharmaceutical regulations and R&D processes is desirabl

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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