PV Risk Management Specialist

🔥 58 minutes ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $112k - $154k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔒 Insurance

👻 Ghost score 0%

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Baxter International Inc.

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 Grant on 2021-04

Healthcare • Manufacturing • Healthcare Insurance

Baxter International Inc. is an innovative, global healthcare leader that offers advanced products, technologies, and therapies to support people in leading healthier, longer lives. The company is committed to meeting the challenges faced by patients, clinicians, and customers in the evolving healthcare landscape, emphasizing resilience and a mission to save and sustain lives.

📋 Description

• Serve as the primary author of Pharmacovigilance Risk Management Plans (PV-RMPs) using global, regional, and local templates • Ensure 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

🎯 Requirements

• 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) • Experience authoring EU Risk Management Plans (RMPs) • 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 • 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 • Applicants must be authorized to work for any employer in the U.S. • Employment visa sponsorship is unavailable

🏖️ Benefits

• Medical and dental coverage starting on day one • Basic life insurance • Accident insurance • Short-term disability insurance • Long-term disability insurance • Business travel accident insurance • Employee Stock Purchase Plan (ESPP) with ability to purchase company stock at a discount • 401(k) Retirement Savings Plan (RSP) with employee contributions and company matching • Flexible Spending Accounts • Educational assistance programs • Paid holidays • Paid time off ranging from 20 to 35 days based on length of service • Family and medical leaves of absence • Paid parental leave • Commuting benefits • Employee Discount Program • Employee Assistance Program (EAP) • Childcare benefits • Discretionary bonuses may be available