Katalyst CRO ยท 3 months ago
Pharmacovigilance Quality Assurance - Sr. Associate
United States
Full-time
Remote
New Grad, Entry LevelKatalyst CRO is a company focused on pharmacovigilance services, and they are seeking a Senior Associate in Pharmacovigilance Quality Assurance. The role involves evaluating vendors, maintaining records within the Quality Management System, and ensuring compliance with regulatory requirements.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Support the evaluation and qualification of vendors, partners, and external organizations involved in PV activities
Conduct and/or assist with supplier pre-qualification surveys
Create and maintain vendor organization records related to PV activities within the Quality Management System (QMS)
Assist in ensuring adverse events (AE) reporting requirements are clearly defined within contracts and agreements
Support the development, implementation, and review of pharmacovigilance Standard Operating Procedures (SOPs)
Collaborate cross-functionally with internal PV, clinical, regulatory, and medical teams to ensure compliance with contractual obligations and regulatory requirements
Where applicable, assist with conducting external audits of PV vendors, CROs, Specialty Pharmacies, and monitoring organizations, including reporting and tracking CAPAs
Support risk-based quality system approaches in line with post-marketing Good Pharmacovigilance Practices (GVP)
Qualification
Required
Basic knowledge of pharmacovigilance principles and AE reporting requirements
Basic knowledge of vendor management and contract management in relation to PV activities (e.g., Patient Support Programs, Specialty Pharmacies, Market Access, Market Research, Named Patient Programs)
Understanding of safety clauses in agreements, including Safety Data Exchange Agreements (SDEA), Master Service Agreements (MSA), and Statements of Work (SOW)
Familiarity with global PV regulations and guidelines (FDA, EMA, ICH)
Strong organizational, analytical, and communication skills
Preferred
Experience in SOP development, process review, and PV/clinical/regulatory documentation
Experience conducting audits of PV vendors, CROs, and Specialty Pharmacies, with the ability to write audit reports and track CAPAs
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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