14 часов назад
PV Risk Management Specialist (Pharmacovigilance)
112 000 - 154 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
PV Risk Management Specialist (Pharmacovigilance): Developing and maintaining Pharmacovigilance Risk Management Plans for Baxter products worldwide with an accent on regulatory compliance, scientific analysis, and cross-functional coordination. Focus on authoring EU and global RMPs, responding to health authority inquiries, managing submission deliverables, and implementing risk minimization measures.
Location: Deerfield, Illinois, United States
Salary: $112,000–$154,000 annually, plus potential discretionary bonuses
Company
develops healthcare products and solutions guided by a mission to save and sustain lives.
What you will do
- Author Pharmacovigilance Risk Management Plans (PV-RMPs) using global, regional, and local templates.
- Coordinate cross-functional review, feedback, approval, and submission activities.
- Respond to regulatory authority questions, requests, and commitments related to PV-RMP submissions.
- Manage project timelines, deliverables, and risk management plan activities.
- Represent Pharmacovigilance Risk Management in cross-functional teams and strategic safety discussions.
- Support risk minimization measures and mentor new team members.
Requirements
- Bachelor’s degree in Nursing, Biological Sciences, Medical, Clinical, or a related field.
- At least two years of pharmaceutical industry experience in Pharmacovigilance, Medical Affairs, Clinical, or related functions.
- Two to three years of experience authoring PV-RMPs, including EU Risk Management Plans.
- Knowledge of European Union and global pharmacovigilance regulations and regulatory submission requirements.
- Strong analytical, critical thinking, project management, communication, and technical writing skills.
- Must be authorized to work for any employer in the United States; visa sponsorship is not available.
Nice to have
- Advanced degree or clinical practice experience.
- Experience with non-EU PV-RMPs, generic EU submissions, or risk minimization activities.
Culture & Benefits
- Culture centered on courage, trust, collaboration, ownership, and accountability.
- Medical and dental coverage starting on the first day.
- Life, accident, disability, and business travel accident insurance.
- 401(k) retirement plan, company stock purchase plan, flexible spending accounts, and educational assistance.
- Paid holidays, paid time off of 20–35 days based on length of service, family and medical leave, and paid parental leave.
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