The Quality Monitor is responsible for performing activities in support of all aspects of Drug Safety and Risk Management (DSRM) functions, including assurance of compliance and investigative activities. This individual is responsible for performing various quality activities in support of DSRM. These activities include, but are not limited to the following: Audit/Inspection Readiness, Training, PV Deviation Investigation Management, Ad-hoc/Aggregate Report QC, ICSR QC, Reconciliation, PV Intelligence, PV Agreement Maintenance, and DSRM Documentation Management. PLEASE REFER TO JOB CODE 17812 WHEN APPLYING FOR THIS POSITION
*Essential Duties and Responsibilities include the following. Other duties may be assigned.:
• Oversees and/or facilitates the completion of Pharmacovigilance Deviation Investigations in collaboration with internal and external stakeholders to identify root cause and CAPA.
• Tracks and trends investigations and their outcomes (CAPA) as a means to ensure continuous improvement.
• Participates in the compilation and presentation of Pharmacovigilance performance metrics (Key Performance Indicators) in collaboration with internal and external stakeholders.
• Participates in and/or facilitates the development and maintenance of PV related procedures.
• Actively work with internal and external stakeholders, as required, in the development/maintenance of DSRM and cross-functional procedures.
• Participates in DSRM training oversight activities in accordance with corporate and regulatory standards
• Supports DSRM Management in the ongoing maintenance of DSRM training matrices, tools/presentations, files, and assignments.
• Provides support in the preparation, facilitation, and close out of audits and inspections.
• Serves as a quality resource for the DSRM organization, providing guidance on DSRM standards of quality oversight and risk remediation.
• Ensures appropriate and consistent application of quality methodologies to day-to-day DSRM activities as per DSRM Quality Standards & Training procedures.
• Performs activities in support of compliance oversight of external groups that impact DSRM deliverables (contractual partners, vendors, client groups, CROs, etc).
Education and/or Experience::
• Bachelor's degree in a scientific, allied health field or related field required.
• At least four years of relevant work experience required; PV experience strongly preferred
• Minimum of one year of Quality Management experience serving in a Quality role in the pharmaceutical/biotechnology or related industry dealing with Good Pharmacovigilance Practice (GPvP) activities, including quality related matters
• Prior experience in participating in audits and GPvP regulatory inspections required.
• Project Management experience preferred.
• Demonstrates expertise related to understanding the principles and application of quality and regulatory compliance.
• Working knowledge of worldwide regulations pertaining to GPvP for pharmaceutical products.
• Excellent analytical problem solving attitude, influencing and interpersonal relationship skills.
• Working knowledge of quality management systems.
• Must be proficient in MS Office Suite.
• Knowledge regarding the use of electronic systems in a regulated environment, including safety databases (ARGUS)
Certificates, Licenses, Registrations: :
Other Skills and Abilities::
• Demonstrates a high degree of pro-activity and independence.
• Possesses strong communication and conflict resolution skills
• Organizational skills required
• Proven ability to manage tasks of significant scope and complexity, while meeting all deliverables and timelines.
• Strong attention to detail and timelines
• Excellent writing, communication, and presentation skills
• Ability to maintain a high level of ethical and compliancy standards
Location: Corporate Office:
This position requires the ability to work on site 5 days per week in the corporate office located in Ardsley,NY.
Physical Demands: :
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
No specific physical demands.
Work Environment: :
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
No specific work demands.
*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Acorda Therapeutics - 20 months ago