Case Management Coordinator - Mississauga, Canada - Labcorp

Labcorp

Verified Company

Mississauga, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

IPV Case Management Coordinator

This position is based in Toronto Canada and will be required to go into the Toronto office once a week.

Primary responsibility
The International Pharmacovigilance (IPV) Case Management Coordinator is to;

Support the IPV Case Management Regional/Team Leads/ and/or Case Management Specialist in all administrative aspects of Individual Case Safety Report (ICSR) case processing and related activities within a country or region
The scope of support is primarily focused on countries. The role holder may be expected to support case management and related activities for other countries within the Americas Region

PRINCIPAL RESPONSIBILITIES:

As applicable, the responsibilities described below may account for cross-country collaborations INBOUND & OUTBOUND ICSR CASE MANAGEMENT

Support with telephone call management answer inbound calls from general public, HCPs, internal colleagues to elicit and capture relevant adverse event data as applicable
Provide administrative support for the 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 as applicable.
Support with the provision of safety information/acknowledgements to marketing partners/other thirdparty partners/Global Medical Safety within the internal and contractual timelines as applicable.
Provide administrative support in performing followup activities for requesting additional information from multiple sources.
Provide archiving support for all ICSR related source documents file, maintain and archive all case related materials in adherence with records retention policies
Provide support with periodic reconciliation activities (e.g. TFUQ/due diligence reconciliation/health authority database) as applicable

COMPLIANCE MONITORING/ACTIVITIES

Support with accurate and timely documentation of deviations to process/timelines, including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs) as applicable.
Support with the administrative tasks of the due diligence process to ensure completeness of reports and timely distribution of followup requests
Support in writing/checking of due diligence letter requests prior to sending
Support with the receipt and management of incoming postal mail as applicable

AUDIT / INSPECTION PREPARATION AND SUPPORT

Support IPV Case Management and/or the LSO, in matters pertaining to audit or inspection preparation or conduct.

OTHER ACTIVITIES

Support other case management related activities such as:

Support IPV Case Management Team Lead / LSO in responding to ad hoc requests (e.g. regulatory authority requests) as applicable.
Support case management related innovation rollout, in collaboration with the IPV Case Management Regional and Team leads
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 or local memo implementation as applicable.

DECISION-MAKING AND PROBLEM-SOLVING:

Collaborate with other IPV Case Management Coordinators, 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.

DELEGATION/BACKUP INFORMATION:

Components of the IPV Case Management Coordinator role may be delegated/backed-up by other

Coordinators or Specialists/associate within a country or region

IPV Case Management Coordinator may also act as backup for the IPV Case Management Team or Regional Lead in Americas if necessary.

WORKING RELATIONSHIPS/INTERFACES:

The IPV Case Management Coordinator will collaborate with other IPV Case Management Coordinators, Specialists/Associate, 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