Pharmacovigilance Quality Assurance Manager
6 days ago
This role is for a highly skilled quality assurance professional with expertise in pharmacovigilance and clinical oversight.
About the Role:The Quality Assurance Manager will lead Civica's pharmacovigilance, product quality complaint, and clinical oversight functions to ensure compliance with regulatory requirements. The role involves establishing and leading pharmacovigilance and product quality complaint functions, ensuring quality and operations systems comply with FDA and other applicable regulations, and performing vendor qualification and re-qualification audits of pharmacovigilance and safety-related vendors.
The successful candidate will have a minimum of 7 years of experience in managing quality assurance processes for pharmacovigilance, product quality complaint, and clinical drug product manufacturing and clinical trial-related activities.
Key Responsibilities:
- Lead interactions with product development personnel regarding clinical compliance matters
- Communicate compliance requirements at all levels
- Ensure visibility to and manage awareness of any noted deviations, issues or deficiencies by escalating to management
- Review of Civica Regulatory filings, Information requests and related reports and technical documentation for compliance with regulations, guidance, and industry standards
- Minimum Bachelor of Science (B.S.), Nursing, or PharmD degree
- Over 7 years of experience in the pharmaceutical industry, preferably in Clinical Quality Assurance and Pharmacovigilance/Safety roles
- Strong interpersonal, verbal and written communication skills including technical writing skills
- Solid problem-solving and critical thinking skills
- Previous experience in preparing for and hosting/responding to regulatory health authority inspections
$120,000 - $150,000 per year, depending on experience
Location:New York, NY, USA (Remote)About Lifelancer:
Lifelancer is a talent-hiring platform connecting professionals with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.
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