Drug Safety Contractor

Prostaffworkforce; Princeton (NJ); Hybrid; USD 70,000 - 110,000; Full time

Benefits offered by this job

Direct deposit

Weekly pay

Medical benefits

401(k) Plan

Job summary

ProStaff Workforce Solutions is seeking a detail-oriented Drug Safety Contractor to join a leading pharmaceutical organization in Princeton, NJ. The role supports pharmacovigilance activities, including intake and processing of adverse drug experiences, medical inquiries, and product quality complaints.

The ideal candidate has 1–4 years of pharmacovigilance experience, strong organizational and communication skills, and the ability to collaborate across regulatory and quality teams in a

Qualifications

• Bachelor's degree preferred.
• 1 to 4 years of pharmacovigilance experience.
• Experience with adverse event processing, medical information, and product quality complaint handling.
• Proficient in Microsoft Office Suite; TrackWise experience is a plus.

Responsibilities

• Receipt and handling of emails, letters and faxes related to ADEs, MIs and PQCs.
• Perform follow ups to obtain additional information.
• Accurately document and track information in applicable systems and databases.
• Coordinate with stakeholders to obtain additional information regarding ADE/PQC/MI.
• Support reconciliation activities.
• Maintain electronic records, paper archives, and controlled documentation in accordance with company policies.
• Assist in the coordination and submission of FDA-mandated reports (PADERs, PSURs, annual/quarterly reports).
• Assist with deviation investigations and CAPA activities, including tracking and documentation.
• Contribute to departmental audit and inspection readiness efforts.
• Tracking and coordination with stakeholders for risk management programs.

Skills

Pharmacovigilance

Adverse event processing

Medical information handling

Product quality complaints handling

Microsoft Office

Organizational skills

Communication skills

Multitasking

Detail oriented

Education

Bachelor's degree

Tools

TrackWise

Job description

We are seeking a detail-oriented Drug Safety Contractor to join a leading pharmaceutical organization in Princeton, NJ. This role will support key pharmacovigilance and drug safety activities, including the intake and processing of adverse drug experiences, medical inquiries, and product quality complaints. The ideal candidate will have hands-on experience in pharmacovigilance, strong organizational skills, and the ability to effectively collaborate with cross-functional stakeholders in a regulated environment.

This is an excellent opportunity for a professional with 1–4 years of pharmacovigilance experience who is looking to further develop their expertise in drug safety operations, regulatory reporting, compliance, and inspection readiness.

Hybrid (3 days onsite/2 days remote)

Contract

Pay rate: DoE

Key Responsibilities

• Receipt and Handling of emails, letters and faxes related to Adverse Drug Experiences (ADEs) Medical Inquiries (MIs) and Product Quality Complaints (PQCs).
• Perform follow ups to obtain additional information.
• Accurately document and track information in applicable systems and databases.
• Coordination with stakeholders to obtain additional information regarding ADE/PQC/MI
• Support reconciliation activities.
• Maintain electronic records, paper archives, and controlled documentation in accordance with company policies.
• Assist in the coordination and submission of FDA-mandated Periodic Adverse Drug Experience Reports (PADERs), Periodic Safety Update Reports (PSURs), annual reports, and quarterly reports.
• Assist with deviation investigations and support corrective and preventive action (CAPA) activities, including tracking and documentation.
• Contribute to departmental audit and inspection readiness efforts
• Tracking and coordination with stakeholders for risk management programs

Qualifications

• Bachelor's degree preferred.
• 1 to 4 years of pharmacovigilance experience.
• Experience with adverse event processing, medical information, and product quality complaint handling.
• Proficient in Microsoft Office Suite
• Experience of working in applications like Track Wise
• Strong organizational, communication, and multitasking skills.
• Detail oriented and adapts to changing circumstances and effectively prioritizes work

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

Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.

Benefits for eligible employees

• Direct deposit
• Weekly pay
• Medical benefits
• 401(k) Plan

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