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Medical Safety/Medical Coding/Pharmacovigilance/Medical Reviewer

Job Title: Sr. Manager, Clinical Safety and Medical Coding

Location: Woodcliff Lake, NJ

Job Description Under the guidance of the Head of Clinical Safety Data Review " Oncology Business Group, manage and review serious adverse events from clinical database to ensure completeness of patient data; review & provide guidance to data management in reconciliation of adverse event between clinical and pharmacovigilance databases; perform, review and/or approve medical coding activities of adverse events, medical history, concomitant therapies, procedures and any other medical fields as needed.

Responsibilities include but not limited to: supervise and review work performed by members of the coding group and clinical data review group; review and approve CRF designs related to coding for all oncology studies; review and approve appropriate codes of reported terms in application systems; maintain coding guidelines and conventions; ensure proper mapping of coded items for analysis; review and issue coding queries as appropriate. Manage process of dictionary upgrading; coordinate the maintenance of synonym lists and coding conventions. .

Review and assists in SAE reconciliation to ensure relevant safety details are in the Clinical database; approve queries by clinical data review group and support clinical summary writing process as needed.

Responsibility also includes participating in the development of standard procedures and related documents as appropriate; collaborates with System administrators for issues relating to coding systems and coding related issue in Clinical database. Coordinate and guide coding specialist in grouping of search terms (medication or AESI) needed for analysis; Coordinate ISS re-coding activities and work closely with data programmers.

Essential Functions

1. Supervise members of the coding and clinical data review in their designated assignments in Oncology studies across Oncology Business Group.
2. Manage and review serious adverse events from clinical database to ensure completeness of patient data;
3. Performs approval of terms, oversees coding query and coding listings for review to study directors and manage requests for grouping of terms e.g medications or AE
4. Review clinical summaries prior to medical review ensuring accurate data is captured and the description of events are medically acceptable
5. Provide guidance to data management in reconciliation of adverse event between clinical and pharmacovigilance database
6. Manages Oncology coding convention, dictionary versioning and maintains grouping of terms and synonym list
7. Coordinates Clinical summaries for regulatory submission
8. Participate in the development and implementation of department standards and documents as needed
Job Qualifications Medical Degree or equivalent is required.
Minimum 7 years experience in Coding
At least 2 years experience in data review
Experience in Clinical Research or Clinical Science or Pharmacovigilance desirable
Familiar with MedDRA and WHODD or other coding dictionary
Experience in managing CRO, global team
Experience with central coding application, DS navigator or any coding application, InForm desirable
Experience in supporting Oncology studies

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