About this opportunity
Prostaffworkforce lists this Drug Safety Associate opportunity in town of mount pleasant, New York. Review the employer’s description below for duties, qualifications and application requirements.
Job description
We are seeking an experienced Drug Safety Associate to join a leading pharmaceutical organization in Hawthorne, NY. 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.
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.
About ProStaff Workforce Solutions
We are a fast growing and successful agency that treats all its clients and candidates with a personal touch. ProStaff Workforce Solutions is a group of industry experts—many hailing from larger agencies—who know their business well and enjoy working in a more hands-on and flexible environment, with attention to detail. Our mission is to match quality people with quality jobs and quality companies to maximize productivity and profitability. We develop long‑term relationships and provide a level of customer service and expertise that instill confidence and trust in our client companies and candidates.
Our Values
Integrity
Commitment
Quality
Diversity
Benefits for eligible employees
Direct deposit
Weekly pay
Medical benefits
401(k) Plan
Please visit us at to explore all opportunities.
#J-18808-Ljbffr
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.