Vice President, Pharmacovigilance


Job Location:

Waltham, MA - USA

Monthly Salary: Not Disclosed
Posted on: 3 hours ago
Vacancies: 1 Vacancy

Job Summary

We are seeking a strategic and accomplished Vice President Pharmacovigilance to lead Decipheras 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 Youll Do

  • Develop and execute the global pharmacovigilance strategy in alignment with corporate objectives regulatory requirements and Decipheras 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 :

Additional Information

Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $335000-$460000. 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 Decipheras 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 help us meet reporting requirements we invite you to complete the confidential survey at the end of this application. Providing this information is entirely optional. It will not be used in the hiring process and will have no impact on your opportunity for employment. The information will be treated confidentially. Deciphera is committed to making all hiring and employment decisions fairly and on a non-discriminatory basis.

 

 

 

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.


Remote Work :

Yes


Employment Type :

Full-time

We are seeking a strategic and accomplished Vice President Pharmacovigilance to lead Decipheras 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 marke...