3 дня назад
Director, Medical Safety (Pharmacovigilance)
185 000 - 252 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director, Medical Safety (Pharmacovigilance): Leading pharmacovigilance activities across clinical development and post-marketing for products addressing serious and rare diseases with an accent on signal detection, risk management, aggregate safety reporting, and regulatory compliance. Focus on developing PV Scientists, evaluating benefit-risk profiles, supporting global regulatory requirements, and implementing AI-enabled tools to improve safety surveillance and operational efficiency.
Location: Fully remote; can be performed from anywhere. Occasional travel for team meetings or events is expected, with travel of up to 15%.
Salary: $185,000–$252,500 annual.
Company
is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.
What you will do
- Lead, mentor, and develop a team of Pharmacovigilance Scientists across products and development programs.
- Oversee signal detection, evaluation, documentation, communication, and safety governance activities for investigational and marketed products.
- Lead Risk Management Plans, risk minimization measures, Core Safety Information, Investigator’s Brochures, product labeling, and aggregate safety reports.
- Provide pharmacovigilance support from first-in-human studies through post-marketing and contribute to benefit-risk assessments.
- Partner with Medical Safety Physicians, Clinical Development, Regulatory Affairs, Biostatistics, Data Management, Clinical Operations, and Quality Assurance.
- Evaluate and implement AI-enabled tools for signal detection, literature surveillance, case review, reporting, data quality, and workflow optimization.
Requirements
- Master’s degree or PhD in Pharmacy, Pharmacology, Life Sciences, Nursing, Public Health, or a related scientific discipline.
- At least 10 years of experience in the pharmaceutical or biotechnology industry and at least 5 years of direct people management experience leading PV Scientists or Medical Safety professionals.
- Experience supporting clinical development and post-marketing pharmacovigilance, including signal management, safety databases, Risk Management Plans, and aggregate safety reports.
- Thorough knowledge of ICH guidelines and FDA, EMA, and global pharmacovigilance regulations.
- Strong leadership, scientific, analytical, project management, communication, and stakeholder-influence skills.
- Strong understanding of AI, automation, and advanced analytics applications in pharmacovigilance, with experience implementing innovative technologies.
Nice to have
- Advanced scientific degree.
- Experience in pulmonary disease, rare diseases, or gene therapy.
- Experience with regulatory inspections, audits, global pharmacovigilance initiatives, safety data visualization, or signal detection methodologies.
- Experience working in a matrixed global organization.
Culture & Benefits
- Remote work with flexible schedules and purposeful in-person collaboration.
- Medical, dental, vision, and mental health coverage, wellbeing reimbursement, and an Employee Assistance Program.
- Paid time off, fertility and family-forming benefits, and caregiver support.
- 401(k) matching, annual equity awards, an Employee Stock Purchase Plan, and company-paid life and disability insurance.
- Learning programs, mentorship, employee resource groups, recognition programs, and volunteer opportunities.
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