Senior Medical Director, Pharmacovigilance, Gastrointestinal And Inflammation (Remote)

8+ years

256,200.00 - 402,600.00

Remote

10 Nov. 27, 2024

Job Description

Job Type: Remote Education: MD/DO 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

Senior Medical Director, Pharmacovigilance – Gastrointestinal and Inflammation (GI²)

Location: Massachusetts - Virtual (Remote)
Company: Takeda Pharmaceuticals

This role focuses on overseeing the medical safety profile and benefit-risk assessment of Takeda’s investigational and marketed products within the Gastrointestinal and Inflammation (GI²) therapeutic area. You will provide strategic, patient-focused leadership while contributing to the development and execution of comprehensive safety strategies. This position involves collaboration across functions, managing global safety activities, and representing safety considerations at internal and external governance levels.

Key Responsibilities

Medical Safety Leadership

Provide strategic leadership for medical safety activities and processes for assigned products in development and the market.
Oversee safety signal detection, benefit-risk assessments, and risk management activities.
Act as the safety lead for the Takeda Safety Board, ensuring timely escalation and resolution of safety issues.

Cross-Functional Collaboration

Lead the Global Safety Team (GST) and Safety Management Team (SMT) for assigned GI products.
Represent safety expertise in cross-functional forums, including program teams and governance bodies like Independent Data Monitoring Committees.
Collaborate with regulatory authorities, ensuring compliance and addressing safety-related inquiries.

Mentorship and Team Oversight

Directly manage a team of Global Safety Leaders (GSLs) and Pharmacovigilance Scientists, mentoring them in safety monitoring and risk management.
Ensure team alignment with corporate objectives and foster professional growth within the PSPV function.

Regulatory and Risk Management

Oversee preparation of materials for regulatory submissions, safety update reports, and interactions with global health authorities.
Lead risk management planning for both investigational and marketed products, ensuring a robust safety framework.

Innovation and Adaptation

Assess emerging safety signals and adapt strategies to address evolving regulatory requirements.
Contribute to safety evaluation during due diligence for new business opportunities.

Operational Excellence

Support initiatives to streamline safety processes and enhance cross-functional communication.
Manage workflow priorities within PSPV to meet evolving organizational needs.

Qualifications and Skills

Education and Experience

Medical Degree (MD) required; advanced degrees are preferred.
8+ years in pharmacovigilance, clinical research, or clinical development within the pharmaceutical industry or academia.
3+ years in leadership and people management roles.
Demonstrated knowledge of global regulatory safety requirements and methodologies.

Skills and Expertise

Proven ability to synthesize complex data and provide clear, actionable safety recommendations.
Extensive experience with benefit-risk assessments and risk management planning.
Strong leadership, mentoring, and team-building skills, with a focus on motivating cross-functional and global teams.
Excellent communication and presentation skills for conveying safety data to diverse audiences.
Proficiency with safety databases and tools for monitoring and assessing safety profiles.

Preferred Attributes

Global and cross-functional collaboration experience.
Ability to anticipate changes in the medical safety landscape and proactively adapt strategies.
Time management expertise to navigate multiple priorities in a dynamic environment.

Work Environment and Benefits

Position Type

Classified as remote, offering flexibility under Takeda’s Hybrid and Remote Work policy.

Compensation

Base Salary Range: $256,200 - $402,600 (varies based on qualifications, experience, and location).
Eligible for short-term and long-term incentives, including comprehensive health, retirement, and well-being benefits.

Additional Benefits

Paid time off, including vacation and sick time.
Tuition reimbursement, volunteer time off, and professional development opportunities.
Participation in Takeda’s innovative and inclusive workplace culture.

Why Join Takeda?

Takeda is a global leader in patient-focused pharmaceutical innovation, offering a dynamic environment that values diversity, collaboration, and professional growth. As a Global Top Employer, Takeda provides the tools and opportunities to make a meaningful impact on patient safety while advancing your career in a cutting-edge field.

If you’re passionate about ensuring patient safety and contributing to innovative therapies in the GI therapeutic area, this role offers the platform to lead and inspire change.

Need assistance preparing your application or insights into interview preparation? Let me know!

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