Associate 1pss

**Principal **Responsibilities**

Triage and classify ICSRs for report type, seriousness, causality, labeling and reporting; prioritize ICSR according to regulatory requirements

Completion of remaining case data entry, including narrative or auto
- narrative

Completion of risk and quality (label, approval, and manual coding). Clarification of unclear or illegible information from the ICSR sender (i.e. local safety officer [LSO] or Call Center)

Liaise with appropriate stakeholders (e.g. Global Medical Safety Operations Physicians [GMSOP], LabCorp Pharmacovigilance Physicians [PVPs]) to clarify appropriate information required for case processing

Prioritization of incoming cases for daily workflow management Participation in assigned projects, including inspection/audit readiness activities and inspection and audits as identified, including interviews and provision of requested data

Other activities relating to case processing as appropriate per case, including but not limited to:

- Single case unblinding, Serious Adverse Event (SAE) reconciliation, deviation memo preparation, deletion/ requests as needed
- Mentoring/training new hires, if required
- Responding to Client in a timely manner
- Involve and support quality improvement trainings and initiatives.

**Quality Review (as** applicable)**:
Perform Quality Review of ICSRs after the data entry. Participate in project teams to improve ICSR quality Document the quality review results and provide feedback to relevant team members

Identify trends in errors and help identify training needs

**Processes & **Procedures**:
Comply with SOPs and Work Instructions (WI) Comply with Client guidance documents

Adhere with MedDRA coding dictionary and MedDRA Points to Consider

Understand relevant safety implications regarding contracts with operating companies and/or marketing partners

Completion of training relating to relevant Pharmacovigilance (PV) Agreements for assigned products

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