Senior Medical Director, Global Drug Safety

5-7 years

Not Disclosed

Boston

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: Senior Medical Director, Global Patient Safety
Location: [Location]
Job ID: [Job ID]
Date Posted: [Date]

Introduction to the Role:
As the Senior Medical Director, Global Patient Safety at Alexion, you will provide global strategic and operational oversight for safety surveillance and risk management across an assigned therapeutic area. You will lead a team of Medical Directors and Safety Scientists responsible for identifying, assessing, and mitigating safety issues throughout the lifecycle of Alexion’s product portfolio. This role requires medical and drug safety expertise, risk-benefit evaluation, and collaboration with cross-functional teams to ensure the safety and regulatory success of Alexion products. The Senior Medical Director reports directly to the Executive Medical Director, Global Patient Safety.

What You'll Do:

Lead Safety Surveillance and Risk Management: Oversee and provide input into safety surveillance, benefit-risk assessments, and risk management activities for Alexion's product portfolio throughout its lifecycle (pre and post-approval).
Lead Medical Team: Direct a team of Medical Directors and Safety Scientists in the identification and resolution of safety signals, ensuring effective communication and risk management plans.
Expert Decision Making: Use your medical and pharmacovigilance expertise to lead decision-making based on complex risk/benefit evaluations, pharmacoepidemiological data, and clinical trial interpretations.
Cross-Functional Collaboration: Partner with internal leaders within Global Patient Safety and across Alexion to integrate pharmacovigilance and risk management support into the business.
Safety Management Team Leadership: Lead Product Safety Management Teams to support key decision-making, develop evidence-based conclusions, and establish next steps for high-priority safety issues.
Regulatory Oversight: Ensure timely and adequate generation of aggregate reports, regulatory responses, and risk management documentation that comply with international regulations.
Risk Minimization: Oversee the development and implementation of risk minimization activities for the assigned product portfolio, ensuring compliance with safety regulations.

What You'll Need:

Medical or Life Sciences Degree: MD or equivalent, or a life sciences/pharmacy/nursing degree, along with extensive Patient Safety or Clinical/Drug Development experience.
Problem-Solving Expertise: Strong problem-solving skills, with the ability to devise innovative solutions to complex issues.
Project Management Skills: Ability to manage multiple overlapping complex tasks and meet deadlines for several projects and sub-projects, including overseeing team members working on these tasks.
Knowledge of Regulatory Standards: In-depth understanding of global safety regulations and the safety deliverables, standards, and processes within the Global Patient Safety (GPS) domain.
Experience in Safety Regulations: Expertise in US and EU safety regulations, both pre- and post-marketing.

Preferred Qualifications:

Relevant Experience: 5-7 years of safety and risk management experience within the pharmaceutical, biotech, or CRO industry, with a focus on Rare, Ultra-Rare, or Orphan Disease Areas.
Excellent Communication Skills: Strong verbal and written communication skills, with the ability to make recommendations that influence decision-making at senior levels.
Independent Judgment: Excellent independent judgment, based on both knowledge and expertise.
Time and Project Management: Strong time-management and project-management skills, including proficiency in Microsoft Word, PowerPoint, and Excel.

Why Alexion:
At Alexion, we are committed to creating a diverse, inclusive team that represents a wide range of perspectives. Our goal is to bring together talented individuals who are passionate about making a difference in patient safety and improving healthcare outcomes globally. We work together, both in the office and remotely, balancing flexibility with collaboration to inspire innovative solutions.

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Senior Medical Director, Global Drug Safety

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