- The Associate Director of Pharmacovigilance Quality Assurance is responsible for execution of the PV quality program.
- Key responsibilities include but are not limited to: providing GVP consultation to pharmacovigilance teams, investigating and documenting PV related quality issues, facilitating CAPA development, developing or contributing to GxP training to business partners, supporting health authority inspections, performing quality reviews/audits of safety related submission documents, conducting or supporting applicable GVP related audits, and performing inspection readiness activities.
- Plans, schedules, conducts, reports, and follows up on PV related audits as assigned
- Communicates audit and quality issue investigation outcomes and monitors compliance to regulations and internal procedures
- Partners with Pharmcovigilance and other R&D functions as appropriate to develop effective corrective actions and preventative actions (CAPAs) to ensure continuous improvement
- Approves CAPAs and reviews for effectiveness. Responsible for maintaining evidence record in support of inspection readiness
- Contributes to the presentation of key quality performance indicators and othe metrics as assigned
- Provides GVP consultation to R&D business partners
- Evaluates R&D systems for optimization and continuous improvement
- Participates in the development, review and approval of standard operating procedures
- Assists with inspection readiness, preparation, and execution activities as assigned
Required Knowledge, Skills, and Abilities
- Minimum 10 years pharmaceutical or biotechnology industry experience, including at least 3 years in Pharmacovigilance
- GVP experience required, GCP, GLP, GMP preferred
Required/Preferred Education and Licenses
- Bachelor’s Degree in Business or Life sciences is required, advance degree is preferred
- ASQ certification or equivalent is preferred
Description of Physical Demands
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
- Occasional public contact requiring appropriate business apparel.
Our company is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any characteristic protected by law.