SciPro · 1 day ago
Associate Director/Director Drug Safety & Pharmacovigilance Quality & Compliance
SD Metro Area
Full-time
Onsite
Lead/Staff, Director/Executive
$180K/yr - $230K/yr
10+ years expSciPro Global is partnered with an exciting company working across therapeutic areas from Cardiometabolic to CNS to Pulmonary that is looking to make a key hire to be responsible for their Quality and Compliance within the Pharmacovigilance and Safety team. The Associate Director/Director Drug Safety & Pharmacovigilance Quality & Compliance would report directly into the Chief Safety Officer, overseeing PV quality systems, compliance oversight, and alliance management.
EmploymentOutsourcingRecruitingStaffing Agency
Hiring Manager
Hannah Wyllie, M.S.Ed.
Responsibilities
Provide strategic leadership and direction for Pharmacovigilance Quality & Compliance activities
Develop and implement an integrated PV quality strategy aligned with organizational objectives and global regulatory expectations
Oversee end-to-end PV quality systems and processes to ensure compliance with global regulations, guidance, and internal policies
Provide Good Pharmacovigilance Practice (GVP) oversight for clinical, post-marketing, and commercial activities to protect patient safety, ensure data integrity, and support effective quality systems
Lead inspection readiness activities and manage preparation, conduct, and follow-up for global regulatory inspections and audits
Partner closely with QA and cross-functional teams to support GCP, GVP, and GMP inspection activities
Monitor regulatory intelligence, industry trends, and emerging global requirements impacting PV systems
Oversee vendor and CRO quality performance, including KPI monitoring and continuous improvement initiatives
Lead the development, maintenance, and governance of PV SOPs, ensuring alignment with current regulations and best practices
Manage, mentor, and develop PV Quality & Compliance team members, fostering a high-performance and collaborative culture
Conduct and oversee internal audits of PV systems, processes, and data
Define and monitor quality metrics to assess effectiveness and identify areas for improvement
Prepare and present quality and compliance metrics, trends, and risk assessments to senior leadership
Drive risk management activities, proactively identifying and mitigating compliance risks within PV systems
Lead CAPA development, execution, tracking, and effectiveness assessments related to pharmacovigilance activities
Support PV issue management, early signal identification, and continuous improvement initiatives
Qualification
Required
10–12+ years of experience in Drug Safety or Pharmacovigilance, with 9–10 years in Quality Assurance and/or Compliance roles
Bachelor's degree (or higher) in Pharmacy, Life Sciences, or a related field
In-depth understanding of global pharmacovigilance regulations, guidance, and industry best practices
Demonstrated experience leading teams and developing talent
Strong analytical, problem-solving, and risk-assessment skills
Experience conducting internal audits and supporting regulatory inspections
Proficiency with pharmacovigilance databases and related systems
Benefits
Bonus
Stock
Company
SciPro
SciPro is a staffing agency specializing in the life sciences field and offers regulatory affairs, biometrics, and clinical operations jobs.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase