HomeJob Details
Return To Job List

Pharmacovigilance Medical Coding Manager


Location: Norwood, Massachusetts
Job Category:



The Role:

Seeking a Pharmacovigilance Medical Coding Manager to provide medical coding guidance for pharmacovigilance activities based on current MedDRA guidance and best practices, including, but not limited to adverse event coding, use of Standard MedDRA Queries, and building Custom MedDRA Queries.

Here’s What You’ll Do:

  • Assist with the development of training materials and job aids for case processing team and review coding process documents under development.

  • Establish medical coding oversight strategy for Moderna ICSR and aggregate reports.

  • Collaborate with the Pharmacovigilance Medical team to develop a Standardized and Custom MedDRA Queries (SMQ and CMQ) standards library for Pharmacovigilance data review and decision support for trend analyses.

  • Ensure coding conventions are therapeutically aligned and meet all regulatory authorities’ requirements.

  • Consult with Pharmacovigilance Medical Leads and Reviewers to resolve medical coding issues/queries.

  • Aid in the development and maintenance of synonym lists to ensure accuracy and consistency of coded data.

  • Participate in data review post dictionary updates to ensure consistency in the recoded data.

  • May participate in SAE coding reconciliations on behalf of Pharmacovigilance Operations, responding to questions from Data Management.

  • Identify gaps in the coding dictionaries, proposing terms to the group for consideration to be submitted to the dictionary vendors.

  • Collaborate with Data Management, Digital and Quality to assess new technologies and innovative solutions in improving the effectiveness and quality of medical coding.

  • Collaborate with Data Management and Clinical Development teams by reviewing and providing input into coding documentation and guidelines for clinical trials, including CRF Completion Guidelines, SAE and Safety Events Reconciliation plans, etc.

 

Here’s What You’ll Bring to the Table:

  • A Bachelor's degree or higher in a life science e.g. Nursing, Pharmacy or in lieu of a degree, equivalent licensure and significant experience in an allied health care field.

  • Minimum 4 years of coding experience using MedDRA in the pharmaceutical industry.

  • A health care professional with understanding of the pathophysiology of disease.

  • In-depth knowledge of MedDRA coding best practices, including Points to Consider. Current MedDRA certification preferred.

  • Ability to work with minimal supervision in a team environment.

  • Direct experience evaluating coding of spontaneously reported adverse events and developing coding conventions and guidance for marketed products.

  • Knowledge of industry best practices, regulatory requirements and GVP.

  • Ability to build successful relationships with cross-functional team members.

  • Outstanding verbal and written communication skills, in addition to excellent organizational skills.

  • Creative, capable problem-solver.


Return To Job List

Apply For This Position - Pharmacovigilance Medical Coding Manager

*First Name:
*Last Name:
*Email:
Address:
City:
State:
Zip:
*Phone:
Cover Letter:
*Resume:
 
Please enter characters below and submit:



Return To Job List