Drug Safety Associate
ProStaff SolutionsHawthorne, New York
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Overview
Education
Nursing (RN, LPN)
Career level
Senior-level
Remote
Hybrid remote
Benefits
Health Insurance
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 ResponsibilitiesPharmacovigilance 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.
- 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.
- 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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FAQs About Drug Safety Associate Jobs at ProStaff Solutions
What is the work location for this position at ProStaff Solutions?
This job at ProStaff Solutions is located in Hawthorne, New York, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at ProStaff Solutions?
Employer has not shared pay details for this role.
What employment applies to this position at ProStaff Solutions?
The employer has not provided this information. This may be discussed during the hiring process.
What experience level is required for this role at ProStaff Solutions?
ProStaff Solutions is looking for a candidate with "Senior-level" experience level.
What education level is required for this job?
The education requirement for this position is Nursing (RN, LPN). Candidates with relevant qualifications or equivalent experience may also be considered.
What benefits are offered by ProStaff Solutions for this role?
ProStaff Solutions offers Health Insurance for this position. Actual benefits may vary depending on the employer's policies and employment terms.
What is the process to apply for this position at ProStaff Solutions?
You can apply for this role at ProStaff Solutions either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.