Vice President, Head of Drug Safety and Pharmacovigilance

The Vice President, Head of Drug Safety & Pharmacovigilance is responsible and accountable for all Drug Safety and PVRM activities related to Sumitomo Pharma Oncology’s pipeline and commercial stage products. This individual will provide proactive leadership and expertise while leading all Drug Safety activities while managing a diverse, hands-on team.


  • Establish and lead a fully integrated Drug Safety and PVRM function to support the needs of SMP Oncology’s development pipeline and commercial stage products.
  • Direct all safety-related regulatory interactions, serving as the key communicator to external parties regarding safety issues for all clinical development programs and SMP Oncology’s commercial products.
  • Monitor safety issues across all development programs ensuring that all safety-related activities comply with applicable local standards and pharmacovigilance exchange agreements with corporate partners.
  • Ensure timely and accurate submission of all safety reports to regulatory authorities and compliance with safety reporting standards.
  • Oversee the establishment and maintenance of SMP Oncology’s global safety database and report generating systems to support timely safety reporting to applicable regulatory agencies.
  • Ensure that all safety related activities comply with all applicable local standards and PV exchange agreements with partners.
  • Represent SMP Oncology at medical/scientific meetings and congresses pertaining to areas of direct responsibility.
  • Prepare and deliver comprehensive updates for assigned areas of responsibility.
  • Establish collaborative and productive relationships with the parent company, internal/external partners, and relevant affiliates.
  • Prepare and deliver comprehensive updates for assigned areas of responsibility.
  • Perform other duties as assigned.


  • MD is required.
  • Minimum 7-10 years of directly related drug safety experience with 3-5 years managing a safety function.
  • Experience with NDA submission, as well as inspections/audit is required.
  • Experience with commercial products is highly preferred.
  • Must possess extensive knowledge and hands-on experience with worldwide regulatory agency reporting requirements as well as direct experience interacting with health agencies/authorities.
  • Highly developed industry acumen and ability to formulate complex strategies, operational plans, and change strategies that address the interests and needs of SMP Oncology.
  • Positive reputation with the FDA and other international regulatory bodies as well as with peers, investigators, etc.
  • Proven ability to investigate and resolve complex safety related issues and make/evaluate proposals for appropriate corrective action.
  • Highly developed understanding of global drug safety dynamics.
  • Direct experience interacting with health agencies and authorities both domestically and globally.
  • Demonstrated ability to align people, policies, and processes to foster a collaborative environment and to sustain collaboration through continual communication of group mission and team-based outcomes.
  • Ability to provide motivational leadership to help the safety organization understand SMP Oncology’s strategy and future goals.
  • Demonstrated skills working within a matrix environment.
  • Ability to work collaboratively with others within and external to the company.

The base salary hiring range for this position is expected to be $324,700 to $438,800 annually. The base salary offered is negotiable and potentially exceeds the hiring range depending on factors such as the candidate’s relevant knowledge, skills, training, certifications and industry-based experience for the role. Our total rewards package also includes the opportunity for merit-based salary increases, short and long-term incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances. Our robust time-off policy includes accrual of 15 vacation days in first year, 13 paid holidays plus additional time off for a shut-down period during the last week of December, access to sick time and our tuition reimbursement program.

Job Location: Remote

Equal Opportunity Employer

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