Vice President, Head of Drug Safety and Pharmacovigilance

Responsibilities

• 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.

Qualifications

• 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.