PV Risk Management Specialist
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Your role at Baxter
Pharmacovigilance Risk Management Specialist
What you'll be doing
- Serve as the primary author of Pharmacovigilance Risk Management Plans (PV-RMPs), using global, regional, and local templates while ensuring compliance with applicable regulatory requirements.
- Lead and coordinate cross-functional review, feedback, and approval processes for PV-RMPs.
- Respond to regulatory authority questions, requests, and commitments related to PV-RMP submissions.
- Independently manage project timelines, deliverables, and submission activities associated with risk management plans.
- Represent Pharmacovigilance Risk Management on cross-functional teams and contribute to strategic safety discussions.
- Partner with country affiliates and global stakeholders to develop, maintain, and complete PV-RMPs and associated risk management commitments.
- Support implementation and management of risk minimization measures and related pharmacovigilance activities.
- Mentor and support training and onboarding of new Pharmacovigilance Risk Management team members.
What you'll bring
- Bachelor's degree in Nursing, Biological Sciences, Medical, Clinical, or a related field.
- Minimum two years of pharmaceutical industry experience in Pharmacovigilance, Medical Affairs, Clinical, or related functions.
- Two to three years of experience authoring Pharmacovigilance Risk Management Plans (PV-RMPs).
- Advanced degree, clinical practice experience, experience with non-EU PV-RMPs, generic EU submissions, or risk minimization activities are preferred.
- Experience authoring EU Risk Management Plans (RMPs) and knowledge of European Union pharmacovigilance requirements.
- Knowledge of global PV-RMP regulations and regulatory submission requirements.
- Strong analytical, critical thinking, and project management skills.
- Excellent written, verbal, and interpersonal communication skills, including the ability to facilitate cross-functional discussions.
- Scientific or clinical knowledge with strong technical writing capabilities.
- Experience interacting with regulatory authorities and addressing health authority inquiries.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $112,000 - $154,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
US Benefits at Baxter (except for Puerto Rico)
Equal Employment Opportunity
Reasonable Accommodations
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