Remote Risk Evaluation and Mitigation Strategies (REMS) Manager
Posted: 03/07/2025 Employment Type: Contract Job Category: Quality and Compliance Job Number: 618251 Is job remote?: Yes Country: United States
Job Description
The REMS manager will provide operational support for the delivery of Risk Evaluation and Mitigation Strategies (REMS) for the safety epidemiology and risk management group. The REMS manager will work closely with REMS team members to ensure REMS compliance, operational excellence and quality documentation is in place for the program.
ROLES AND RESPONSIBILITIES
Support delivery of REMS activities to agreed timelines according to company quality standards and REMS procedures.
Conduct reconciliation of various REMS data sources including compliance data, shipment data, Key performance indicator data to ensure proper oversight and compliance of the REMS program
Manage the REMS shared mailbox, respond to REMS queries and triage questions/issues as needed for resolution amongst REMS team members
Manage REMS specific issues and escalations, as applicable
Coordinate regular team meetings; track outstanding action items and activities per the project plan
Help manage and reconcile contracts, POs and invoices
Support REMS processes and procedures with execution of key deliverables
ESSENTIAL
Bachelors degree (preferably in medical or biological science) or equivalent by experience.
At least 5-7 years of relevant clinical/medical experience in the pharmaceutical industry, with experience in pharmacovigilance and/or quality assurance
Previous demonstration of basic project management skills including tracking deliverables
Strong communication skills and fluency in English
Prior experience tracking metrics and/or compliance and safety data including trending and interpreting data
Detail oriented and
Proficient in Microsoft applications
Broad knowledge and understanding of FDA regulations and compliance requirements in a GxP (Good [x] Practice) environment
DESIRABLE
Prior REMS experience
Project Management Certification
Audit or Inspection experience Working with third-party vendors
Apply Now
Job Description
The REMS manager will provide operational support for the delivery of Risk Evaluation and Mitigation Strategies (REMS) for the safety epidemiology and risk management group. The REMS manager will work closely with REMS team members to ensure REMS compliance, operational excellence and quality documentation is in place for the program.
ROLES AND RESPONSIBILITIES
Support delivery of REMS activities to agreed timelines according to company quality standards and REMS procedures.
Conduct reconciliation of various REMS data sources including compliance data, shipment data, Key performance indicator data to ensure proper oversight and compliance of the REMS program
Manage the REMS shared mailbox, respond to REMS queries and triage questions/issues as needed for resolution amongst REMS team members
Manage REMS specific issues and escalations, as applicable
Coordinate regular team meetings; track outstanding action items and activities per the project plan
Help manage and reconcile contracts, POs and invoices
Support REMS processes and procedures with execution of key deliverables
ESSENTIAL
Bachelors degree (preferably in medical or biological science) or equivalent by experience.
At least 5-7 years of relevant clinical/medical experience in the pharmaceutical industry, with experience in pharmacovigilance and/or quality assurance
Previous demonstration of basic project management skills including tracking deliverables
Strong communication skills and fluency in English
Prior experience tracking metrics and/or compliance and safety data including trending and interpreting data
Detail oriented and
Proficient in Microsoft applications
Broad knowledge and understanding of FDA regulations and compliance requirements in a GxP (Good [x] Practice) environment
DESIRABLE
Prior REMS experience
Project Management Certification
Audit or Inspection experience Working with third-party vendors
Apply Now