Provide strategic leadership and oversight of Takeda's global pharmacovigilance operations, ensuring the timely, accurate, and compliant collection, assessment, processing, review, and reporting of ...
Provide strategic leadership and oversight of Takeda's global pharmacovigilance operations, ensuring the timely, accurate, and compliant collection, assessment, processing, review, and reporting of ...
Provide strategic leadership and oversight of Takeda's global pharmacovigilance operations, ensuring the timely, accurate, and compliant collection, assessment, processing, review, and reporting of ...
Provide strategic leadership and oversight of Takeda's global pharmacovigilance operations, ensuring the timely, accurate, and compliant collection, assessment, processing, review, and reporting of ...
Payer Back Office Strategy / Technology / Operations Consultant, Senior Associate
Boston, MA · On-site
$77K - $202K/yr
These individuals analyse client needs, develop operational strategies, and offer guidance and support to help clients streamline processes, improve productivity, and drive business performance. As ...
Payer Back Office Strategy / Technology / Operations Consultant, Senior Associate
Boston, MA · On-site
$77K - $202K/yr
These individuals analyse client needs, develop operational strategies, and offer guidance and support to help clients streamline processes, improve productivity, and drive business performance. As ...
You will own operational strategy and study execution across the product lifecycle, from early concept and feasibility through validation, regulatory submission, launch, and post-market evidence ...
You will own operational strategy and study execution across the product lifecycle, from early concept and feasibility through validation, regulatory submission, launch, and post-market evidence ...
Executive Director, Head of PV Operations Oversight
Boston, MA · On-site
$238K - $374K/yr
Provide strategic leadership and oversight for global pharmacovigilance (PV) operations, ensuring timely, accurate, compliant collection, processing, evaluation, reporting, and compliance management ...
Executive Director, Head of PV Operations Oversight
Boston, MA · On-site
$238K - $374K/yr
Provide strategic leadership and oversight for global pharmacovigilance (PV) operations, ensuring timely, accurate, compliant collection, processing, evaluation, reporting, and compliance management ...
The Opportunity We are seeking a Senior Business Operations & Strategy Manager to help drive strategic decision-making, operational excellence, and cross-functional alignment across our Payments ...
Quick apply
The Opportunity We are seeking a Senior Business Operations & Strategy Manager to help drive strategic decision-making, operational excellence, and cross-functional alignment across our Payments ...
The Opportunity We are seeking a Senior Business Operations & Strategy Manager to help drive strategic decision-making, operational excellence, and cross-functional alignment across our Payments ...
The Opportunity We are seeking a Senior Business Operations & Strategy Manager to help drive strategic decision-making, operational excellence, and cross-functional alignment across our Payments ...
The Opportunity We are seeking a Senior Business Operations & Strategy Manager to help drive strategic decision-making, operational excellence, and cross-functional alignment across our Payments ...
The Opportunity We are seeking a Senior Business Operations & Strategy Manager to help drive strategic decision-making, operational excellence, and cross-functional alignment across our Payments ...
Develop operational strategy and clinical operations plans to support the execution of the Clinical Development Plan * Support the selection, oversight, and management of CROs and other vendors
Develop operational strategy and clinical operations plans to support the execution of the Clinical Development Plan * Support the selection, oversight, and management of CROs and other vendors
Director, Clinical Operations
Burlington, MA · On-site
$90 - $135/hr
This individual will combine hands-on operational leadership with strategic contribution to companies clinical development plans while upholding our core working behaviors of Trust and Respect ...
Quick apply
Director, Clinical Operations
Burlington, MA · On-site
$90 - $135/hr
This individual will combine hands-on operational leadership with strategic contribution to companies clinical development plans while upholding our core working behaviors of Trust and Respect ...
VP, Technical Operations
Waltham, MA · On-site
$291K - $359K/yr
Summary The Vice President, Technical Operations will lead end-to-end CMC Technical Operations strategy across Drug Substance, Drug Product, and CMC Program Management, advancing small-molecule ...
VP, Technical Operations
Waltham, MA · On-site
$291K - $359K/yr
Summary The Vice President, Technical Operations will lead end-to-end CMC Technical Operations strategy across Drug Substance, Drug Product, and CMC Program Management, advancing small-molecule ...
This role sets clinical operations strategy for their assigned program(s) or indications, leads and develops a team of clinical operations professionals (which may include Clinical Trial Associates ...
Quick apply
This role sets clinical operations strategy for their assigned program(s) or indications, leads and develops a team of clinical operations professionals (which may include Clinical Trial Associates ...
Business Strategy Manager
Boston, MA · On-site
As a business strategy manager, you will work at the intersection of corporate, customer, M&A, workforce, and operational strategy; working among strategic advisors to help our clients shape their ...
Business Strategy Manager
Boston, MA · On-site
As a business strategy manager, you will work at the intersection of corporate, customer, M&A, workforce, and operational strategy; working among strategic advisors to help our clients shape their ...
Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan * Partner and collaborate with cross-functional stakeholders such as the Project ...
Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan * Partner and collaborate with cross-functional stakeholders such as the Project ...
Payer Back Office Strategy / Technology / Operations Consultant, Manager
Boston, MA · On-site
$99K - $232K/yr
These individuals analyse client needs, develop operational strategies, and offer guidance and support to help clients streamline processes, improve productivity, and drive business performance. As ...
Payer Back Office Strategy / Technology / Operations Consultant, Manager
Boston, MA · On-site
$99K - $232K/yr
These individuals analyse client needs, develop operational strategies, and offer guidance and support to help clients streamline processes, improve productivity, and drive business performance. As ...
Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan * Partner and collaborate with cross-functional stakeholders such as the Project ...
Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan * Partner and collaborate with cross-functional stakeholders such as the Project ...
WHAT WE DO Our Strategy and Operations consultants work with clients at all levels of the organization, from the C-suite to the shop floor, helping them to deliver on their most strategic initiatives.
WHAT WE DO Our Strategy and Operations consultants work with clients at all levels of the organization, from the C-suite to the shop floor, helping them to deliver on their most strategic initiatives.
Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan * Partner and collaborate with cross-functional stakeholders such as the Project ...
Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan * Partner and collaborate with cross-functional stakeholders such as the Project ...
The Business Analyst acts as a strategic business partner, translating initiatives into actionable ... Analyze large operational datasets to identify trends, inefficiencies, capacity constraints, and ...
The Business Analyst acts as a strategic business partner, translating initiatives into actionable ... Analyze large operational datasets to identify trends, inefficiencies, capacity constraints, and ...
Corporate Leadership & Strategic Operations • Serve as a member of the Executive Leadership Team and participate in corporate strategy development. • Lead day-to-day company clinical operations ...
Corporate Leadership & Strategic Operations • Serve as a member of the Executive Leadership Team and participate in corporate strategy development. • Lead day-to-day company clinical operations ...
Operations Strategy information
See Boston, MA salary details
$74.4K - $93.7K
2% of jobs
$93.7K - $113K
8% of jobs
$125.3K is the 25th percentile. Wages below this are outliers.
$113K - $132.3K
23% of jobs
$132.3K - $151.7K
16% of jobs
The median wage is $153.1K / yr.
$151.7K - $171K
14% of jobs
$171K - $190.3K
11% of jobs
$192.4K is the 75th percentile. Wages above this are outliers.
$190.3K - $209.6K
9% of jobs
$209.6K - $228.9K
7% of jobs
$228.9K - $248.2K
4% of jobs
$248.2K - $267.5K
3% of jobs
$267.5K - $286.8K
2% of jobs
$74.4K
$169.2K
$286.8K
How much do operations strategy jobs pay per year?
What is operations strategy?
How does an operations strategy professional typically collaborate with cross-functional teams to drive process improvements?
What are the key skills and qualifications needed to thrive in operations strategy, and why are they important?
What is the difference between Operations Strategy vs Supply Chain Analyst?
| Aspect | Operations Strategy | Supply Chain Analyst |
|---|---|---|
| Required Credentials | Bachelor's in Business, Operations Management, or related field; MBA often preferred | Bachelor's in Supply Chain, Logistics, Business, or related field; certifications like CSCP beneficial |
| Work Environment | Strategic planning teams, management meetings, cross-department collaboration | Data analysis, vendor communication, logistics coordination, office setting |
| Employer & Industry Usage | Manufacturing, retail, logistics companies focusing on overall operations | Supply chain firms, manufacturing, retail, logistics companies focusing on supply chain processes |
Operations Strategy focuses on developing and implementing high-level plans to improve overall operational efficiency and effectiveness. In contrast, Supply Chain Analysts concentrate on analyzing and optimizing supply chain processes to ensure smooth logistics and inventory management. Both roles are essential in operations but differ in scope and focus.
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Executive Director, Head of PV Operations Oversight
Boston, MA • On-site
Full-time
Posted 29 days ago
Takeda Pharmaceuticals rating
7.3
Based on 71 frontline employees who took The Breakroom Quiz
Job description
Job Description
Objective / Purpose:
The Executive Director, Head of Pharmacovigilance Operations Oversight provides strategic leadership and oversight for Takeda's global pharmacovigilance operations, ensuring the effective collection, processing, evaluation, reporting, and compliance management of safety information across the product lifecycle.
This role is accountable for the operational performance of global case processing, Individual Case Safety Report (ICSR) management, regulatory reporting, tracking of market research / patient support programs (MR / PSP), performing PV review and approval of digital assets and social media programs before launch, and oversight of pharmacovigilance service providers. The position serves as the primary business leader for PV operational strategy, vendor governance, inspection readiness, and continuous process improvement, ensuring delivery of high-quality, compliant, and efficient pharmacovigilance operations that support patient safety and meet global regulatory requirements.
The Executive Director leads a global team responsible for PV operational execution while driving innovation, digital transformation, and operational excellence across Takeda's pharmacovigilance ecosystem.
Accountabilities:
1. PV Operations Leadership
- Provide strategic leadership and oversight of Takeda's global pharmacovigilance operations, ensuring the timely, accurate, and compliant collection, assessment, processing, review, and reporting of safety information across the product lifecycle.
- Establish and execute the global PV Operations strategy, governance frameworks, organizational objectives, and operating model to support Takeda's evolving safety portfolio and business priorities.
- Oversee pharmacovigilance activities related to case intake, case processing, medical coding, triage, quality review, Individual Case Safety Reports (ICSRs), regulatory reporting, market research programs, patient support programs, and Takeda-sponsored digital assets and social media initiatives.
- Ensure appropriate forecasting, resource planning, and operational scalability to support global business needs while maintaining high standards of quality, compliance, and patient safety.
- Serve as the executive sponsor for pharmacovigilance service providers, strategic vendors, and outsourcing partnerships, ensuring effective governance, operational delivery, quality performance, and regulatory compliance.
- Establish and maintain comprehensive vendor oversight frameworks, including governance structures, performance management, financial stewardship, quality controls, and compliance monitoring.
- Lead Joint Operating Committees, Executive Governance Committees, and strategic business reviews to drive accountability, continuous improvement, and long-term partnership success.
- Partner with Finance and Procurement to oversee budgets, contracts, statements of work, invoicing, and vendor investment strategies.
- Ensure global PV operational activities remain compliant with applicable regulations, guidance, and industry standards, including FDA, EMA, PMDA, MHRA, ICH, and other global health authority requirements.
- Partner with Quality Assurance to maintain effective quality systems, vendor oversight procedures, audit programs, quality agreements, and inspection readiness activities.
- Provide executive leadership during regulatory inspections, partner audits, and internal assessments, ensuring effective remediation, CAPA implementation, and sustainable compliance improvements.
- Maintain robust monitoring programs, operational controls, performance metrics, SOPs, policies, and standards that support ongoing compliance, quality, and operational effectiveness.
- Drive continuous improvement, operational excellence, and digital transformation initiatives across the global pharmacovigilance ecosystem.
- Identify and implement opportunities to enhance efficiency, quality, scalability, and compliance through process optimization, automation, artificial intelligence, advanced analytics, and innovative technologies.
- Lead strategic transformation programs, including operating model evolution, process harmonization, technology implementations, and enterprise-wide optimization initiatives.
- Establish and monitor operational performance indicators, dashboards, and business metrics that enable data-driven decision-making and continuous improvement.
- Build, lead, and develop a high-performing global organization through talent development, coaching, succession planning, and leadership excellence.
- Foster a culture of accountability, inclusion, engagement, innovation, continuous learning, and patient-centricity across the PV Operations organization.
- Collaborate closely with PSPV leadership, QPPV, Regulatory Affairs, Quality, Clinical Development, Medical Affairs, DQS, and other cross-functional stakeholders to align operational strategies with enterprise objectives.
- Influence senior leaders and external partners to advance strategic priorities, strengthen organizational effectiveness, and deliver sustainable business outcomes.
Education & Competencies (Technical and Behavioral):
- Bachelor's degree in life sciences, healthcare, pharmacy, or related discipline. Advanced degree preferred.
- Minimum 15 years of experience in the pharmaceutical or healthcare industry
- Minimum 10 years of progressive experience in PV operations and safety reporting.
- Demonstrate the ability to work across geographies.
- Significant experience overseeing global case processing and regulatory reporting activities and leading global teams within a regulated environment.
- Demonstrated experience managing global CROs, strategic vendors, and outsourcing partnerships.
- Experience with Argus, ArisG, or other enterprise safety systems and associated technologies.
- Deep expertise in global pharmacovigilance operations, case management, and reporting requirements.
- Strong understanding of global PV regulations, GVP, FDA, EMA, ICH, and international compliance frameworks.
- Exceptional leadership, communication, and stakeholder management skills.
- Strong vendor governance and strategic partnership management capabilities.
- Demonstrated ability to influence senior leaders and drive organizational change.
- Excellent analytical, problem-solving, and decision-making abilities.
- Strong financial and operational management acumen.
- Proven ability to lead in complex, matrixed, global organizations.
- Strong project and program management skills.
- Commitment to quality, compliance, and patient safety.
- Ability to prioritize competing demands and operate effectively in a fast-paced environment.
Travel Requirements:
- Up to 15% domestic and international travel may be required to support global operations, vendor governance activities, inspections, audits, and business meetings.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Boston, MA
U.S. Base Salary Range:
$238,000.00 - $374,000.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
For information about our benefits, please click here.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
What Takeda Pharmaceuticals employees say
Pay
Benefits
Hours and flexibility
Workplace
Get the full story on Breakroom
About Takeda Ventures
Sourced by ZipRecruiter
Industry
Investment clubs and venture capital companies, pharmaceutical product wholesalers and pharmaceutical and medicine manufacturing
Company size
1 - 10 Employees
Headquarters location
San Diego, CA, US