Skills Alliance · 5 days ago
Vice President, Pharmacovigilance & Drug Safety
Greater Seattle Area
Full-time
Hybrid
Director/Executive
$370K/yr - $430K/yr
10+ years expSkills Alliance is a clinical-stage targeted oncology company focused on developing innovative therapies for cancer patients. They are seeking a Vice President of Pharmacovigilance & Drug Safety to lead global safety efforts, providing strategic vision and operational oversight for drug safety while ensuring regulatory compliance worldwide.
RecruitingStaffing Agency
Responsibilities
Develop and implement the pharmacovigilance strategy in alignment with regulatory requirements and company goals
Build and develop a team of drug safety professionals to evaluate and oversee safety reporting and management
Oversee the collection, analysis, and reporting of safety data from ongoing clinical trials
Oversee the development of drug safety databases and reporting procedures to ensure regulatory compliance
Lead the preparation and submission of safety reports, including Periodic Safety Update Reports and other regulatory filings
Lead the safety analysis for regulatory submissions including NDAs, BLAs and MAAs
Ensure compliance with global regulatory requirements and guidelines, including those from the FDA, EMA, and ICH
Collaborate with Clinical Development, Regulatory Affairs, and Quality Assurance teams to ensure integrated approaches to drug safety. Provide expert safety guidance during development of protocols and other site-facing documents
Provide expert guidance on risk management and mitigation strategies throughout the product lifecycle
Conduct regular training for staff on pharmacovigilance practices and regulatory updates
Analyze safety data trends and provide actionable insights to senior management and stakeholders
Represent the pharmacovigilance function in meetings with regulatory authorities and during audits
Provide medical expertise to clinical teams in evaluation of safety events
Qualification
Required
M.D., D.O., or equivalent advanced degree in life sciences or pharmacology required; additional training in oncology or drug safety highly preferred
A minimum of 10 years of pharmacovigilance and drug safety experience in biotech and/or pharmaceutical settings, including a minimum of 5 years in a senior leadership role with global responsibilities
Strong knowledge of global pharmacovigilance regulations and industry standards. Deep expertise in global pharmacovigilance regulations (FDA, EMA, ICH, MHRA, PMDA) and evolving industry best practices
Proven track record of managing safety data and conducting signal detection and risk assessment. Proven ability to lead signal detection, aggregate safety data review, benefit–risk assessment, and implementation of proactive risk management strategies
Demonstrated ability to build a highly functioning team. Demonstrated success in building, mentoring, and scaling high‑performing global pharmacovigilance and drug safety teams
Excellent communication, leadership, and interpersonal skills
Ability to work collaboratively in a fast-paced, dynamic environment
Strong analytical and problem-solving skills
Preferred
additional training in oncology or drug safety highly preferred
Company
Skills Alliance
Skills Alliance is a staffing & consulting agency that mainly recruits life sciences and medical technology professionals.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2022-08-02Acquired
Recent News
Real Deals Magazine
2022-08-02
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