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.
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
Required Qualifications
Preferred Qualifications and Competencies
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 https://www.prostaffworkforce.com/ to explore all opportunities.
#IND1
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.
- 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.
- 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.
- 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.
- 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 https://www.prostaffworkforce.com/ to explore all opportunities.
#IND1
Numbers & Facts
| Location | Hawthorne, New York |
| Industry | Staffing/Employment Agencies |
| Company Size | 100 to 499 employees |
| Website | http://prostaffnj.com/ |
About Company
ProStaff is unlike other staffing or recruiting agencies.
We are a fast growing and successful agency that treats all its clients with a personal touch. Headquartered in South Amboy, ProStaff Solutions is a small 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.We all pick up the phones, so it’s not unusual to get our executives on the line when you call. We want to be accessible and accountable to you.
What makes us unique?
Customer service and responsiveness are required of everyone who works at ProStaff. Our mission is to bring the right people to the right job every time. This is not easy, but it can be done.
To accomplish this, we make the effort to learn about your needs and use a careful screening process before we do any introductions. We value your time. If we bring you the wrong candidates or send you to the wrong companies, we’re not doing our job.
ProStaff can handle rush orders with skill, but we always understand our clients before proceeding. That’s why many people are loyal to us. We have worked with blue chip names such as Bed, Bath and Beyond and US Foods, as well as internet-based newcomers such as Blue Apron and Burlington Coat Factory.
Underlying ProStaff’s success are these values:
- Hard work
- Integrity
- Honesty
- Helping the communities we serve
When we uphold our values, ProStaff Solutions Maintains Its good name–which is of utmost importance to us. It’s the heart of our business.
Skills
- Adverse Eventsunmatched
- Best Practicesunmatched
- Biotech and Pharmaceuticalunmatched
- Clinical Informationunmatched
- Communication Skillsunmatched
- Corporate Complianceunmatched
- Corrective Actionunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Cross-Functionalunmatched
- Customer Support/Serviceunmatched
- Detail Orientedunmatched
- Diversityunmatched
- FDA Requirementsunmatched
- Health Planunmatched
- Healthcareunmatched
- Maintain Complianceunmatched
- Medical Productsunmatched
- Medical Recordsunmatched
- Medical Treatmentunmatched
- Multitaskingunmatched
- Negotiation Skillsunmatched
- Nursingunmatched
- Organizational Skillsunmatched
- Pharmacovigilanceunmatched
- Pharmacyunmatched
- Presentation/Verbal Skillsunmatched
- Productivity Managementunmatched
- Profit & Lossunmatched
- Quality Managementunmatched
- Reconciliationunmatched
- Record Keepingunmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Regulatory Requirementsunmatched
- Regulatory Submissionsunmatched
- Risk Managementunmatched
- Root Cause Analysisunmatched
- Safety Data Agreementsunmatched
- Safety Standardsunmatched
- Surveillanceunmatched
- Team Playerunmatched
- Time Managementunmatched
- Vendor/Supplier Managementunmatched
- Writing Skillsunmatched
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