Associate Director Pharmacovigilance

The Quality Assurance (QA) Associate Director, Pharmacovigilance, will lead Civica, Inc. (“Civica”) pharmacovigilance and complaint intake, triage, and processing in developing and supplying essential generic and biosimilar medicines, including combination products by bringing their knowledge and experience to serve patients and pursue excellence in quality and compliance.

The QA Associate Director, Pharmacovigilance, will lead Civica, Inc. (“Civica”) pharmacovigilance and complaint intake, triage, and processing in developing and supplying essential generic and biosimilar medicines, including combination products by bringing their knowledge and experience to serve patients and pursue excellence in quality and compliance. The QA Associate Director, Pharmacovigilance is responsible for leading the pharmacovigilance program within the Quality System to ensure compliance with cGMP requirements, SOPs and regulatory standards for Civica’s product portfolio across generics and biosimilars, including combination products.

The QA Associate Director, Pharmacovigilance, will have a minimum of ten (10) years related experience in managing processes for pharmacovigilance, product quality complaints and adverse events. As a leader, the QA Associate Director, Pharmacovigilance possesses competencies including, but not limited to, continuous process improvement, analyzing information, strategic planning, written and verbal communication, instilling excellence, attention to detail, problem solving and addressing complex situations.

The position is a remote role.

• Lead Civica pharmacovigilance function including but not limited to:
• Civica’s pharmacovigilance program complies with applicable regulations and industry best practices.
• Oversight of Civica’s third party call center for intake and triage of AE, PQC, and Medical Inquiries
• Establish quality checks for AE case intake, triage, data entry, medical assessment, seriousness/expectedness/causality assessment, reportability, follow-up, and regulatory submissions.
• Oversight of case processing for adverse events where Civica is Market Authorization Holder
• Oversite of authoring of PADER by the pharmacovigilance service provider
• Monthly reconciliation of partner cases
• Lead PV activities for new product introduction or discontinuation
• Support safety signal evaluation, benefit-risk assessment, and safety related decision making
• Ensure, adverse drug events, and medical device reports are investigated and reported, and followed up on as necessary
• QA support in inspection preparation and hosting pharmacovigilance related regulatory inspections, including pre-inspection and follow-up activities
• Support of vendor qualification and re-qualification audits of pharmacovigilance and safety related vendors as needed to support business needs and ensure compliance
• Management of Safety Data Exchange Agreements with Private Label Manufacturers and Market Authorization Holders
• Trending and analyzing complaint data
• Communicate compliance requirements at all levels
• Ensure visibility to and manage awareness of any noted deviations, issues or deficiencies by escalating to management
• Management and reporting of metrics to Civica leadership
• Establish procedures for combination product complaints and implement PV system for combination products with device quality assurance
• Review and assess changes to regulatory requirements and industry best practices and facilitate implementation through new or revised processes
• Perform other related duties as required

• Degree in a health care profession such as BSN, RN, NP, PharmD, PA, DO, MD.
• Over ten (10) years of experience in the pharmaceutical…