Job Description

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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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