About this opportunity
Prismhr Hire lists this Associate Director Pharmacovigilance opportunity in lehi, Utah. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Job Description:
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.
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.
Essential Duties and 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
Basic Qualifications and Capabilities:
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
Experience in establishing a PV program as Market Authorization Holder is a plus.
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
Physical Demands and Work Environment:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.
While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.
The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.
Minimal travel requirements with occasional travel to Civica or other facilities as warranted.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.