Job Description

We are seeking an experienced Drug Safety Associate to join a leading pharmaceutical organization in Princeton, NJ . This position will play a key role in supporting U.S. pharmacovigilance operations, ensuring compliance with applicable regulatory requirements, and maintaining high standards of safety and quality.

If you are an experienced pharmacovigilance professional looking to take on a role with broad U.S. drug safety responsibilities, we encourage you to apply today.

Hybrid (3 days onsite/2 days remote)

Contract

Pay rate: DoE

Key Responsibilities

Pharmacovigilance Operations

• Oversee external vendors responsible for case intake and medical information.
• Support pharmacovigilance activities for U.S. operations.
• Track and perform follow-up activities to obtain additional clinical or safety information when required.
• Review, log, and document adverse event reports, medical information inquiries, and product quality complaints in accordance with company procedures.
• Ensure timely forwarding of safety cases to appropriate internal and external stakeholders in accordance with applicable agreements and reporting requirements.
• Conduct reconciliations of adverse events, medical information, and product quality complaint records.

Compliance & Quality Management

• Maintain electronic safety records and archives in compliance with company procedures and regulatory requirements.
• Monitor compliance with FDA regulations, pharmacovigilance agreements, and internal procedures.
• Assist with regulatory inspection readiness and audit preparedness activities.
• Support audits, inspections, and responses to regulatory requests.
• Identify reporting delays and support root cause analyses (RCA) and corrective and preventive actions (CAPA).
• Ensure procedural deviations are appropriately documented and addressed.

Regulatory Reporting

• Responsible for Aggregate Report Calendar Preparation for US and ensuring compliance
• Review and publish periodic safety reports in eCTD format for electronic submission.
• Support electronic regulatory submissions through applicable agency gateways and systems.

Risk Management

• Ensure active participation in REMS, handle REMS inspections, provide approvals on behalf of company. Share documents with relevant stakeholders as needed.
• Collaborate with cross-functional teams and external partners to ensure program compliance.

Safety Data Exchange Agreement (SDEA) Management

• Act as drug safety representative for SDEAs, collaborate internal and external stakeholders, maintaining oversight of PV obligations outlined within SDEA
• Author, Review, negotiate, and provide pharmacovigilance input for new and revised SDEAs to ensure compliance with applicable regulatory requirements and company standards.

Required Qualifications

• Bachelor's degree in Nursing, Pharmacy or a related healthcare discipline.
• Minimum 7 years of pharmacovigilance/drug safety experience.
• Strong understanding of adverse event reporting, safety surveillance, and regulatory compliance requirements.
• Minimum 3 years of experience with safety databases, TrackWise, case processing, periodic reports.
• Knowledge of FDA pharmacovigilance regulations and industry best practices.
• Experience managing vendors.
• Excellent written and verbal communication skills.

Preferred Qualifications and Competencies

• Experience supporting audits, inspections, CAPA, and compliance activities.
• Experience preparing electronic regulatory submissions (eCTD).
• Experience with working on business partner agreements.
• Risk management program experience in a pharmaceutical environment.
• Ability to work independently with minimal supervision.
• Strong organizational and multitasking skills.
• Excellent attention to detail and quality focus.
• Ability to manage competing priorities in a deadline-driven environment.
• Effective stakeholder management and collaboration skills.
• Flexible and adaptable work style.

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