Pharmacovigilance Quality, and Compliance Manager
Proclinical is currently recruiting for a Pharmacovigilance Quality, and Compliance and Training Senior Manager for a global pharmaceutical company located in Bedminster, NJ. Successful candidate will be responsible for the oversight of all quality aspects of Global Pharmacovigilance and Risk Management organization, including assurance of compliance and investigative activities.
- Develop strategy and vision to set departmental standards for quality and training.
- Provide a compliance evaluation and review function for GPV procedures.
- Develop and report pharmacovigilance compliance metrics related to GPV activities.
- Determine escalation procedures for issues arising from GPV and drives GPV across-functional process improvement activities.
- Establish and maintain effective cross - functional team communications to advance company's quality activities and promote best practices.
- Ensure GPV readiness for pharmacovigilance inspections and audits.
- Collaborate with Quality department to ensure the effective management and conduct of audits and inspections and to promote a successful PV Quality Management System.
- Serve as the GPV point of contact for quality matters pertaining to PV-related quality assurance activities.
- Maintain a contemporary knowledge of current industry trends, standards and methodologies relating to PV quality management and ensures their sound application within the department.
- Develop and present summaries on quality issues, initiatives and projects at cross-functional meetings.
- Serve as a strategic and technical expert for production of PV quality metrics and compliance reports.
- Develop, maintain, and ensure the effectiveness of SOPs and instructions related to GPV Quality, Compliance and Training function.
- Develop and implement measures to oversee GPV training compliance and effectiveness.
- Responsible for training and mentoring colleagues on the Quality and Compliance team.
- Lead quality pharmacovigilance activities for the GPV Department.
- Manage through cross-functions, business partners and CROs. Responsible for the successful implementation and management of activities contributing to quality pharmacovigilance management.
Skills and Requirements:
- Bachelor's degree in a scientific, allied health field or related field required, advanced degree preferred.
- 7+ years of relevant work experience required.
- 5+ years of progressive experience serving in a Quality role in the pharmaceutical/biotechnology or related industry dealing with Good Pharmacovigilance Practice (GPV) activities, including quality related matters, and experience in conducting audits and hosting GPV regulatory inspections.
- Demonstrates broad and deep expertise related to understanding the principles and application of quality and regulatory compliance.
- Strong knowledge of worldwide regulations pertaining to GPV for pharmaceutical products, including FDA, ICH and EU GVP; PMDA a plus.
- Strong knowledge and experience in auditing and inspections, including development of responses.
- Prior experience in the management, development and implementation of a risk-based global PV & QA Audit program in support of clinical safety and pharmacovigilance activities.
- Advanced knowledge of quality management systems, including systematic approaches to process improvement required.
- Knowledge regarding the use of electronic systems in a regulated environment, including those implemented in support of drug safety, training oversight, and documentation management.
- Preferred Skills/Qualifications:
- Strong oral and written communication skills
- Excellent written, communication, and presentation skills.
- Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.
- Demonstrated leadership and project management skills.
- Advanced ability to effectively communicate and influence the outcomes of the decision-making process.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Yannick Dada (+1) 646-741-8433 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.