Rems Pharmacovigilance Operations Lead Jobs

Review and monitor regional risk management programs.

Author SOPs as needed/requested by PSRM management. Review existing SOPs and author updates as required.

Key responsibilities for this role include:

The minimum qualifications for this role are:

Access – Providing high quality trusted medicines regardless of geography or circumstance;

Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and

Ensure the drafting / revision of all quality documents inherent in the vigilance responsibilities,

Implement a routine PV system meeting all FDA and HHCHC HC requirements,

Promote, maintain, and improve compliance with pharmacovigilance regulatory requirements,

Implement systems to measure compliance with agency regulatory requirements ,

Adequate theoretical and practical knowledge for the performance of pharmacovigilance activities,

Carry out periodic reconciliations aimed at confirming the proper handling of all vigilance reports,

• Support US REMS and ex-US Risk Management Program operational data and reporting requirements

• Support for active monitoring of products that require risk management programs

• Categorize REMS and ex-US Risk Management Program required reports in the REMS Strategy & Operations dashboard

• Track and trend categories of REMS and ex-US Risk Management Program and vendor required reports

• Assist with reconciliation activities performed for US REMS and ex-US Risk Management Programs

Experience with ARGUS/ARISg), MedDRA and WHO drug dictionary

1 or More Years of PV experience and knowledge of FDA regulations required

Education Qualifications (from an accredited college or university)

Bachelor's Degree in nursing, pharmacy, or healthcare related field preferred

Ensure NIH Clinical Center Pharmacy’s policy and procedures are incompliance with requirements by local regulation and the Sponsor.

Interact with IDCU/IVAU managers and Pharmacy QC/QA team.

Eight (8) years of experience in a science related field.

Demonstrates expert knowledge working in the research laboratory environment.

This is a long-term contract position which offers:

- Competitive compensation and comprehensive benefit package

Expert knowledge and proven track record of REMS management and operations

Recent Pharmaceutical industry experience with patient services and/or vendor management

Oversight and management of Risk Evaluation and Mitigation Strategies (REMS) day-to-day activities

Liaise with specialty pharmacies to ensure that all REMS requirements and processes are managed and maintained

Manage day-to-day activities of Risk Evaluation and Mitigation Strategies (REMS) program to maintain regulatory compliance

Assess and implement ongoing REMS process and service-related improvements to ensure continuity and patient satisfaction while fostering a positive prescriber experience