Vice President, Pharmacovigilance

Deciphera Pharmaceuticals, Inc.

Waltham (MA)

On-site

USD 335,000 - 460,000

Full time

2 days ago
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Benefits offered by this job

Annual bonus
401(k) match
Medical benefits
Parental leave

Job summary

Deciphera Pharmaceuticals, Inc. seeks a strategic Vice President of Pharmacovigilance to lead global drug safety, regulatory compliance, and benefit-risk assessment for investigational and marketed products.

This executive will set safety governance and propel pharmacovigilance operations across Clinical Development, Regulatory Affairs, Medical Affairs, Quality, and Commercial teams. The role requires extensive leadership in PV, deep regulatory knowledge, and a track record of interactions with

Qualifications

  • 15+ years in pharmacovigilance or clinical safety within biotech/pharma.
  • 8+ years leading global pharmacovigilance or patient safety organizations.
  • Deep understanding of FDA, EMA, ICH, GCP and related requirements.
  • Experience with safety governance, risk management, signal detection, and inspections.

Responsibilities

  • Develop and execute the global pharmacovigilance strategy aligned with corporate objectives and regulatory requirements.
  • Provide executive leadership for benefit-risk evaluation, safety governance, safety surveillance, signal management, and risk management.
  • Represent Pharmacovigilance in governance committees, leadership forums, and interactions with health authorities.
  • Ensure global pharmacovigilance activities are compliant, inspection-ready, and aligned with regulatory standards and internal quality systems.
  • Establish scalable pharmacovigilance systems, processes, and partnerships to support a growing global portfolio.
  • Lead and develop a high-performing pharmacovigilance organization with a culture of scientific excellence and patient-focused decision making.

Skills

Pharmacovigilance leadership
Global regulatory knowledge
Strategic safety leadership
Risk management
FDA/EMA knowledge
Cross-functional collaboration

Education

MD/DO/PharmD/PhD or equivalent

Job description

Deciphera, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines and providing hope to people living with cancer, neurologic and autoimmune disease. Deciphera is leveraging its proprietary switch‑control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. In addition to advancing multiple product candidates from Deciphera’s platform in clinical studies, QINLOCK® (ripretinib) is Deciphera’s switch‑control kinase inhibitor approved in many countries including the European Union and the United States for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. ROMVIMZA® (vimseltinib) is a kinase inhibitor approved in the United States for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity, and in the European Union for adult patients with TGCT associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability.

The spirit of collaboration that has brought medications to life continues to guide how we operate, grow, and discover new breakthroughs. We cultivate an inclusive culture that values curiosity, creativity, and shared accountability - empowering individuals to challenge the unknown together.

Deciphera offers competitive compensation, including equity‑based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.

Job Description

We are seeking a strategic and accomplished Vice President, Pharmacovigilance to lead Deciphera’s global drug safety and pharmacovigilance function. This executive leader will be accountable for patient safety, regulatory compliance, and proactive benefit‑risk assessment across investigational and marketed products. The VP will set the vision for safety governance, product safety strategy, risk management, regulatory safety support, and pharmacovigilance operations while partnering closely across Clinical Development, Regulatory Affairs, Medical Affairs, Quality, Commercial, Technical Operations, and other key functions.

What You’ll Do
  • Develop and execute the global pharmacovigilance strategy in alignment with corporate objectives, regulatory requirements, and Deciphera’s commitment to patient safety.
  • Provide executive leadership for benefit‑risk evaluation, safety governance, safety surveillance, signal management, and risk management across investigational and marketed products.
  • Serve as a senior safety advisor to executive leadership and represent Pharmacovigilance in governance committees, leadership forums, and interactions with health authorities.
  • Ensure global pharmacovigilance activities are compliant, inspection‑ready, scientifically rigorous, and aligned with applicable regulatory requirements, GCP standards, and internal quality systems.
  • Establish and evolve scalable pharmacovigilance systems, processes, quality frameworks, vendor partnerships, and operational capabilities to support a growing global portfolio.
  • Build, develop, and lead a high‑performing pharmacovigilance organization while fostering a culture of scientific excellence, accountability, collaboration, and patient‑focused decision making.
Qualifications
  • MD, DO, PharmD, PhD, or equivalent advanced scientific or healthcare degree.
  • 15+ years of progressive experience in pharmacovigilance, clinical safety, drug safety, or drug development within the biotechnology or pharmaceutical industry.
  • 8+ years of leadership experience managing global pharmacovigilance, clinical safety, or patient safety organizations.
  • Demonstrated experience supporting products across clinical development and commercialization.
  • Deep understanding of global pharmacovigilance regulations, guidelines, and industry best practices, including FDA, EMA, ICH, GCP, and other applicable requirements.
  • Experience with safety governance, benefit‑risk assessment, signal detection, risk management, safety reporting, and inspection readiness.
  • Track record of successful health authority interactions, regulatory inspections, audits, and cross‑functional safety leadership.
  • Strong strategic leadership, communication, decision‑making, and stakeholder management skills.
Preferred Experience
  • Oncology experience strongly preferred.
  • Experience supporting small molecule therapeutics.
  • Prior experience leading pharmacovigilance activities for commercial‑stage products.
  • Experience working in a global, outsourced operating model utilizing CROs and external pharmacovigilance vendors.
  • Demonstrated success building, scaling, and evolving pharmacovigilance organizations, systems, and operating models.
  • Experience supporting regulatory submissions, product launches, and post‑marketing safety activities in multiple global markets.
  • Strong business acumen with the ability to align safety strategy with corporate objectives.
Additional Information

Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $335,000-$460,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.

Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera’s competitive total rewards strategy that also includes annual performance bonus, a long‑term incentive plan, full range of benefits and other incentive compensation plans (if applicable)

Benefits:
  • Competitive salary and annual bonus.
  • Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
  • Generous parental leave and family planning benefits.
  • Outstanding culture and opportunities for personal and professional growth.
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non‑discriminatory basis.

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