Clinical Pharmacovigilance Data Manager

Company History:

Integrium is looking for a Clinical Pharmacovigilance Data Manager in our Tustin, CA office. The Clinical Pharmacovigilance Data Manager is responsible for monitoring the ongoing collection of clinical data and informing the Drug Development Team of any drug safety issues arising during and after the conducting of Clinical Drug Trial(s). He/she will be reviewing, and processing data which will be accessed with a data browser from a variety of laboratory data portals and import them into a variety of pharmacovigilance monitoring databases where data trends are viewed for purposes of identifying potential safety signals during a clinical drug trial. Furthermore, the Clinical Pharmacovigilance Data Manager will be expected to code adverse events and coordinate medications during clinical trials in accordance with MeDRA and WHODrug dictionaries for classification and tabulation to reveal any data trends pertinent to drug safety. This position will also be required to retrieve, process, and work on notifications of Serious Adverse Events. This includes: receiving the initial Serious Adverse Events reports from participating trial sites, engaging trial investigators where necessary to ensure the completeness of the submitted data, and write the first draft notifications for the Medical Director’s review. Lastly, periodic reviews of Serious Adverse Events data for drug safety trends will be expected.

Job summary:

Integrium is looking for a Clinical Pharmacovigilance Data Manager in our Tustin, CA office. The Clinical Pharmacovigilance Data Manager is responsible for monitoring the ongoing collection of clinical data and informing the Drug Development Team of any drug safety issues arising during and after the conducting of Clinical Drug Trial(s). He/she will be reviewing, and processing data which will be accessed with a data browser from a variety of laboratory data portals and import them into a variety of pharmacovigilance monitoring databases where data trends are viewed for purposes of identifying potential safety signals during a clinical drug trial. Furthermore, the Clinical Pharmacovigilance Data Manager will be expected to code adverse events and coordinate medications during clinical trials in accordance with MeDRA and WHODrug dictionaries for classification and tabulation to reveal any data trends pertinent to drug safety. This position will also be required to retrieve, process, and work on notifications of Serious Adverse Events. This includes: receiving the initial Serious Adverse Events reports from participating trial sites, engaging trial investigators where necessary to ensure the completeness of the submitted data, and write the first draft notifications for the Medical Director’s review. Lastly, periodic reviews of Serious Adverse Events data for drug safety trends will be expected.

Education/Experience:

  • Minimum Master’s degree or foreign equivalent degree in Healthcare Administration, Public Health, Pharmacy or related field.
  • Minimum One (1) year experience as a Clinical Data Manager, Project Medical Scientist, or related occupation, including experience in receiving, reviewing, and processing central and local laboratory data.
  • Experience supporting a drug development program, receiving, reviewing, and classifying medical case records submitted by trial-participating clinical research centers.
  • Previous experience working on database programs such as MS Access, SQL, DSG, Medrio, and Trial Works.
  • Experience collecting medical safety documentation and ensuring completion of the medical files for clinical endpoints and Serious Adverse Events as well as maintaining the healthcare and safety database, and medical information systems.

Integrium also provides a benefits package that includes:

  • Health Insurance
  • Dental and Vision plan
  • Prescription Drug plan
  • Life Insurance
  • FSA
  • 401(k) Plan

Equal Opportunity/Affirmative Action Employer

Integrium, LLC strongly supports and values the uniqueness of all individuals and promotes a work environment where diversity is embraced.