Head, Patient Safety & Pharmacovigilance (Pspv) Strategy & Operations Office (Vice President)

10+ years

Not Disclosed

Abilene

10 Nov. 27, 2024

Job Description

Job Type: Full Time Education: PhD/MS/MBA 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 Director, Patient Safety & Pharmacovigilance (PSPV) Strategy & Operations

Location: Boston, MA (Hybrid)
Company: Takeda Pharmaceuticals

This leadership role within Takeda’s Patient Safety & Pharmacovigilance (PSPV) organization provides an opportunity to drive the strategic direction of PSPV operations, ensuring global compliance, operational excellence, and alignment with Takeda’s overall mission and objectives. The position requires significant experience in the pharmaceutical industry, leadership in global teams, and the ability to manage complex projects and organizational change.

Key Responsibilities

Strategic Direction and Leadership

Collaborate with the Head of PSPV and the PSPV Leadership Team to define and execute PSPV strategies that drive innovation and align with Takeda’s broader R&D goals.
Oversee the PSPV function's strategic direction, ensuring cross-functional connectivity and the successful execution of PSPV projects and commitments.
Serve as a strategic partner, addressing current and future initiatives, project management, and budget considerations across PSPV.
Ensure alignment of PSPV strategies with corporate initiatives, working closely with other departments within Takeda.

PV Operations and Compliance

Lead the Global PV Operations function, ensuring compliance with regulatory guidelines, SOPs, and industry best practices.
Maintain inspection readiness globally and ensure that PV operations meet Takeda’s standards for safety, quality, and efficiency.
Drive transformative operational excellence initiatives across the PV Operations function, in alignment with Takeda’s R&D and enterprise strategies.

PV Excellence and Innovation

Guide the development of functional visions and strategies for PSPV, driving operational excellence and interdepartmental efficiencies.
Oversee the Takeda Safety Board Office (TSBO) and ensure its operational excellence.
Lead global PV educational efforts, fostering collaborations and driving the development of educational materials and initiatives for internal and external stakeholders.

Performance, Value, and Resource Management

Optimize budget and resource allocation, managing PSPV expenditures in collaboration with the Finance team.
Oversee the performance tracking of PSPV functions and ensure value creation across the organization.
Accountable for the delivery of strategic outcomes, ensuring the successful execution of PSPV initiatives.

People and Culture

Contribute to the development of an organizational culture that attracts, retains, and develops top talent within PSPV.
Foster a collaborative, inclusive, and innovative environment, ensuring effective communication across PSPV and with other teams.
Lead global PSPV communications, including Town Halls and department meetings, to maintain transparency and foster community.

Collaboration and Engagement

Act as the primary point of contact for senior leaders across R&D, Communications, Finance, HR, Digital, Procurement, and other key departments.
Drive integration and alignment of strategic initiatives across different functions, ensuring cross-functional collaboration and reporting.

Qualifications and Skills

Education and Experience

PhD/MS/MBA or equivalent advanced degree.
10+ years of relevant experience in the pharmaceutical industry, with significant experience in drug development and clinical research.
8+ years of line or matrix management experience, demonstrating leadership and the ability to drive results.

Skills

Strong understanding of pharmaceutical operations and regulatory compliance.
Proven track record of leading and implementing business process transformation and organizational change.
Experience in senior management roles, with the ability to influence and engage senior stakeholders.
Exceptional communication skills, with the ability to distill complex issues and lead across functions and regions.
Ability to drive innovation, challenge the status quo, and implement risk-taking strategies.

Leadership and Decision-Making

Experience in making complex decisions with broad enterprise impact.
Ability to inspire teams, drive engagement, and influence at all organizational levels.
Strong executive presence and leadership confidence, with the ability to drive results and deliver on complex business deliverables.

Complexity and Innovation

Ability to navigate complex global environments and lead change across multiple regions and functions.
Comfortable with challenging conventional methods and driving innovative solutions.

Work Environment and Benefits

Position Type: Hybrid (some travel required).
Compensation: Base salary range is competitive based on qualifications and experience, with eligibility for short-term and long-term incentives, medical, dental, and vision benefits, 401(k) matching, paid vacation, sick time, and more.

Why Takeda?

Takeda offers the chance to be part of a world-class organization focused on transforming patient care through innovative therapies. With a commitment to global leadership in patient safety, this role provides an opportunity to make a meaningful impact on public health while fostering professional growth and leadership development in a dynamic and collaborative work environment.

If you're ready to shape the future of pharmacovigilance and contribute to life-changing therapies, this is the opportunity for you!

Would you like more assistance in preparing your application or interview strategy for this role?

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