Auftragsdetails

The Pharmacovigilance Compliance Manager is responsible for the monitoring, reporting, and management of metrics and key performance indicators (KPIs) related to pharmacovigilance compliance for the Key Account programs. The Pharmacovigilance Compliance Manager is responsible for monitoring, reporting on, and ensuring that quality and compliance activities are performed in accordance with policies, guidelines, current regulatory requirements, and other relevant standards both globally and regionally. They maintain distinctively high quality and compliance as the operating standards for all processes and exhibit a commitment to continuous improvement in these areas. The Pharmacovigilance Compliance Manager is responsible to ensure that the programs are prepared for regulatory and client inspections and audits.

*6 to 12 month project position

• KPI oversight, reporting, and management of associated CAPAs with the PV Key Account Programs per agreed frequency
• Oversight and management of the Quality Management Plans relevant to Key Accounts
• Oversight and management of the Pharmacovigilance Safety Master File (PSMF)
• Collaborate on project specific SOPs, Work Instructions, etc. managing the process for the PV related documents
• Support development and filing of deviations within eQMS and associated CAPAs
• Working knowledge of PV regulations pertaining to the countries and regions specific to the Key Accounts programs
• Audit and inspection leadership, inspection readiness and support
• Development of any/all audit and inspection report responses, including CAPA development and implementation
• Participation in client meetings as needed
• Run end of line QA reports, identify performance trends, and opportunities for ongoing improvement, reporting plans and executing changes as needed
• Provide Change Management Oversight
• Provide feedback for development of training materials as needed
• Other duties as assigned

• Maintain understanding of and ensure compliance with global drug/biologic/device regulations, 21 CFR Part 820, ICH guidelines, EU-CTR
• Proficient computer knowledge and computer keyboarding skills including intermediate proficiency with Microsoft Office Suite (Outlook, Word, Excel)
• Excellent organization and prioritization skills with superior attention to detail
• Able to work independently and collaboratively
• Able to occasionally work extended and/or flexible schedule to meet client requirements
• University/Bachelor’s degree or Associate degree with equivalent work experience
• Required: 5+ years of experience in pharmaceutical or medical device industry, or equivalent.
• Required: 2+ years of experience in Drug Safety or Pharmacovigilance role
• Preferred: Experience analyzing data

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All candidates must be legally eligible to work in the United States. Employees can work remotely in this role, from the US.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***