ACARA Jobs
Senior Manager/Associate Director, PV Quality and Compliance (CW)
Apply- ID: 524543
- Posted: 3/15/2023
- Location: Brisbane, CA
- Category: Pro - Professional
- Job Type: Temporary
- Duration: 9 - 12 Months
Description
Acara Solutions is looking for a Senior Manager/Associate Director, PV Quality and Compliance (CW) for our client located in Brisbane, CA
- Serves as Subject Matter Expert (SME) for PV quality and compliance activities.
- Supports internal and external global PV activities related to Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP), industry standards and regulations.
- Oversees and manages quality and compliance activities and key performance indicators/metrics supporting the PV Quality Management System (QMS).
- Implements effective monitoring and controls that ensure activities supporting the PV system are robust and aligned with applicable regulations.
- Partners with clients functions to identify and implement processes supporting PV compliance.
- Contributes to Pharmacovigilance System Master File (PSMF) development and maintenance.
- Contributes to department SOPs.
- KPI development, maintenance, and implementation for Drug Safety and Pharmacovigilance organization
- Reporting of PV compliance metrics related to the department
- Training compliance oversight and reporting
- Deviation and CAPA management
- Drug Safety and PV documentation management and archiving for inspection readiness
- Collaboration with client Quality to support PV audits and inspections
- PSMF development and maintenance
- Escalates quality and compliance issues to management
- Effective cross-functional collaboration to advance department activities
Pay and Benefits:
- The Salary for this position is $ 85.00 per hour (Max Pay rate).
Job Requirements
Required Skills / Qualifications:
- Bachelor's degree a scientific or allied health or medical
- Minimum of 7 years of increasing responsibility and relevant experience in the global pharmaceutical industry
- Minimum of 5 years of pharmacovigilance, quality, and compliance experience
- Minimum of 5 years' experience in PC literacy
Preferred Skills / Qualifications:
- Experience in global setting.
- MS Office skills (Outlook, Word, Excel, PowerPoint, Project)
- Knowledge of Argus Safety Database
- Experience with safety database migration
- Advanced knowledge of pharmacovigilance and regulations including FDA, EU, MHRA, Health Canada and ICH
Additional Information:
- Upon offer of employment, the individual will be subject to a background check and a drug screen
- Regularly needed to operate standard office equipment (personal computer, photocopy machine)
- Ability to work on a computer for extended periods of time.
- Regularly needed to sit for long periods of time, and occasionally stand and walk.
- Regularly needed to use hands to operate a computer and other office equipment.
- Close vision is needed for computer usage.
- Occasionally needed to stoop, kneel, climb, and lift up to 20 pounds.
- Occasional travel
Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct, and Aleron's strategic partner, SDI) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.
Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.