PV Risk Management Specialist

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Act as the main author of Pharmacovigilance Risk Management Plans (PV-RMPs) utilizing global, regional, and local templates.

• Ensure adherence to relevant regulatory standards.

• Lead and facilitate the cross-functional review, feedback, and approval processes for PV-RMPs.

• Address inquiries, requests, and commitments from regulatory authorities regarding PV-RMP submissions.

• Independently oversee project timelines, deliverables, and submission activities linked to risk management plans.

• Represent Pharmacovigilance Risk Management in cross-functional teams and engage in strategic safety discussions.

• Collaborate with country affiliates and global stakeholders to develop, maintain, and finalize PV-RMPs and related risk management commitments.

• Assist in the implementation and management of risk minimization measures and associated pharmacovigilance initiatives.

• Provide mentorship and support for the training and onboarding of new members of the Pharmacovigilance Risk Management team.

⛳️ Requirements

• Bachelor’s degree in Nursing, Biological Sciences, Medical, Clinical, or a related discipline.

• At least two years of experience in the pharmaceutical industry within Pharmacovigilance, Medical Affairs, Clinical, or similar roles.

• Two to three years of experience in authoring Pharmacovigilance Risk Management Plans (PV-RMPs).

• Experience in authoring EU Risk Management Plans (RMPs).

• Familiarity with European Union pharmacovigilance regulations.

• Understanding of global PV-RMP regulations and regulatory submission criteria.

• Strong analytical, critical thinking, and project management abilities.

• Exceptional written, verbal, and interpersonal communication skills.

• Capability to facilitate discussions across different functions.

• Scientific or clinical knowledge with robust technical writing skills.

• Experience in interacting with regulatory authorities and addressing inquiries from health authorities.

• Applicants must be authorized to work for any employer in the U.S.

• Employment visa sponsorship is not available.

🏝️ Benefits

• Medical and dental coverage starting from day one.

• Basic life insurance.

• Accident insurance.

• Short-term disability insurance.

• Long-term disability insurance.

• Business travel accident insurance.

• Employee Stock Purchase Plan (ESPP) allowing the purchase of 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.