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Senior Director, Risk Management - Rems

7+ years
Not Disclosed
12 Dec. 17, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: REMS Process Owner
Location: Flexible (Hybrid Working Model)
Experience Level: 5+ years in the pharmaceutical industry
Qualification: Bachelor’s degree in Science/Pharmacy/Nursing

Company Overview:
At AstraZeneca, we are pioneers in science, committed to transforming lives through groundbreaking treatments. We are focused on eliminating cancer as a cause of death, integrating cutting-edge science with advanced technology to expedite breakthroughs in oncology. Our collaborative environment fosters innovation, and we are seeking passionate individuals to join our team and contribute to life-changing medicines.

Role Overview:
We are looking for a REMS Process Owner to lead and manage our REMS (Risk Evaluation and Mitigation Strategies) programs. In this role, you will ensure compliance with relevant regulations and AstraZeneca policies while driving the success of our REMS programs. You will manage REMS vendors, define KPIs, develop and implement REMS processes, and oversee documentation, all while ensuring timely execution and audit preparedness. As the REMS subject matter expert, you will collaborate with various departments to ensure effective implementation and continuous improvement.

Key Responsibilities:

  • Lead REMS strategy, design, and evaluation plans in collaboration with the Risk Management Director/Senior Risk Management Director and associated stakeholders.
  • Oversee REMS vendors and contractors, managing contracts, budgets, and purchase orders.
  • Ensure timely execution of REMS activities, and author/review REMS-related documentation including FDA requests.
  • Author and implement REMS-related procedures, processes, and templates.
  • Monitor external regulatory changes impacting REMS and update internal processes to align with new requirements.
  • Ensure audit preparedness and regulatory inspection support for REMS.
  • Identify risks and issues within REMS processes and propose solutions to mitigate them.
  • Lead REMS training strategy and collaborate with US training departments.
  • Drive the development and enhancement of REMS standards, techniques, and technology.
  • Represent AstraZeneca externally when required, and actively contribute to short-term and long-term objectives of the Risk Management group.

Essential Skills and Experience:

  • Bachelor's degree in Science, Pharmacy, or Nursing.
  • Minimum of 5 years in the pharmaceutical industry, with at least 3 years in patient safety/pharmacovigilance.
  • Expert knowledge and experience in REMS operations, including FDA requirements and risk management strategies.
  • Proven ability in project management, training development, and auditing/inspection activities related to REMS.
  • Experience with REMS vendor management and authoring standards documents (SOPs).
  • Strong communication, strategic thinking, and presentation skills.

Desirable Skills and Experience:

  • Global Patient Safety experience (beyond the US).

Why AstraZeneca?
We are passionate about science and dedicated to improving millions of lives. With a flexible, hybrid working model, we offer you the autonomy to thrive while being part of a collaborative and innovative environment. Join us in making a lasting impact on cancer treatment and contributing to a diverse and inclusive team.