Associate Director Pharmacovigilance

Civica Rx•Lehi, UT

11h•Remote

About The Position

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 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.

Requirements

Degree in a health care profession such as BSN, RN, NP, PharmD, PA, DO, MD.
Over ten (10) years of experience in the pharmaceutical industry, preferably in Pharmacovigilance / Safety roles for marketed products
3-5 years of experience managing pharmacovigilance quality management systems including investigation of deviations, CAPA, and change controls
Demonstrated understanding of GXP requirements for compliance with domestic and international regulations including those of the US FDA and other applicable agencies in biologics, oral solid dosage product and/or combination products
Strong interpersonal, verbal and written communication skills including technical writing skills
Must understand a variety of quality systems that support the product development lifecycle and post marketing arena
Solid problem solving and critical thinking skills
Previous experience in preparing for and hosting/responding to regulatory health authority inspections
Ability to lead projects with minimal supervision required; to work independently and in a team-based environment
Ability to effectively plan, organize, monitor, execute, and measure success of a project
Ability to anticipate and adjust to rapidly changing priorities and anticipate the impact of the change on overall program
Demonstrated ability to develop and implement business processes and process improvements

Nice To Haves

Experience in establishing a PV program as Market Authorization Holder is a plus.

Responsibilities

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