Case Management Coordinator

3 weeks ago

Mississauga, Canada Labcorp Full time

**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 third-party partners/Global Medical Safety within the internal and contractual timelines as applicable.
- Provide administrative support in performing follow-up 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 follow-up 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 roll-out, 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 back-up 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
- A degree in life or pharmaceutical sciences is preferred.
- Essential knowledge & skills
-

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