As applicable, the responsibilities described below may account for cross-country collaborations
INBOUND & OUTBOUND ICSR CASE MANAGEMENT
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 (seek support from senior specialist as applicable)
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, materiovigilance, or cosmetovigilance (as applicable).
AGGREGATE REPORTING
Support timely submission of aggregate safety reports (e.g. DSUR, PSUR etc. applicable) to applicable health authorities, in collaboration with local medical safety input (as applicable).
COMPLIANCE MONITORING
Ensure accurate and timely documentation of deviations to process/timelines, including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs) as applicable.
AUDIT / INSPECTION PREPARATION AND SUPPORT
Support the LSO, in matters pertaining to audit or inspection preparation or conduct.
OTHER ACTIVITIES
Ensure and support other case management related activities such as:
Vendor training, on-going vendor support on a case level (daily or as required), case review, and vendor oversight(daily or as required)
Local literature screening for ICSRs and potential safety signals (in consultation with local medical safety as needed).
Periodic reconciliation activities
Support IPV Case Management Team Lead / LSO in responding to ad hoc requests (e.g. regulatory authority requests) as required.
Support case management related innovation roll-out, in collaboration with the IPV Case Management Regional and Team leader
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. Support critical project works
DECISION-MAKING AND PROBLEM-SOLVING:
Collaborate with other IPV Case Management Specialists, 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.
REPORTING RELATIONSHIPS:
The IPV Case Management Specialist is an employee of IPV. IPV is part of GMS (Global Medical Safety).
Reporting line
Reports directly to the applicable IPV Case Management Team Lead Dotted reporting line to the LSO (only if this is explicitly mandated by local regulatory requirements)
DELEGATION/BACKUP INFORMATION:
Components of the IPV Case Management Specialist role may be delegated/backed-up by other Specialists within a country or collaboration network (as applicable). IPV Case Management Specialist may also act as back-up for the IPV Case Management Team Lead if necessary.
WORKING RELATIONSHIPS/INTERFACES:
The IPV Case Management 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/OCMS 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
Consumer Care Center
Global Clinical Operations Local Operating Company personnel
EDUCATION & EXPERIENCE REQUIREMENTS:
Academic qualification
A degree in life, health or pharmaceutical sciences is preferred.
Essential knowledge & skills
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 within
Experience Proven expertise and experience in pharmaceutical regulations and R&D processes is desirable