MANAGER PV DEVIATION INVESTIGATOR LAWRENCEVILLE, NJ Role is 50% onsite (Hybrid) A minimum of five (5) years pharmaceutical industry experience, with a minimum of three (3) years in pharmacovigilance, drug development, clinical development, or regulatory affairs. 5+ years in deviation investigations.
Required Skills:
A Bachelor's degree with the minimum years of experience required.
A minimum of five (5) years pharmaceutical industry experience, and with a minimum of three (3) years in pharmacovigilance, drug development, clinical development, or regulatory affairs.
5+ years in deviation investigations.
Ability to support and lead deviation investigations using a systematic and process driven methodology. Includes, under the direction of senior staff, the ability to utilize key root cause analysis tools/techniques (e.G., Five Why's, Is/Is not, cause-and-effect diagram (fishbone), etc.).
Ability to support and lead CAPA development using a systematic and process driven methodology. Includes, under the direction of senior staff, the ability to utilize key root cause analysis tools/techniques (e.G., Five Why's, Is/Is not, cause-and-effect diagram (fishbone), etc.).
Ability to meet set targets for completion of tasks, monitor milestones, report risks and ensure completion of tasks both as an individual and within a team using project management techniques.
Ability to work on assigned tasks and has an ability to carry out most tasks without needing to be supervised or managed by another member of the team.
As a member or part of a high-performance teams, has an ability to work in a collaborative manner and work in a team/matrixed setting.
Ability to deliver on assigned tasks with high standards, high productivity and meeting established standards set by department management.
Responsive to feedback provided by peers and management. Additionally, is able to provide clear, concise and constructive feedback on key CAPA and deviation deliverables to customers.
Maintains skills to perform successful and creative negotiation of difficult compliance issues. Ability to ascertain when to escalate issues to PV Compliance and Inspection Readiness management.
Demonstrated ability to work in a complex, changing environment and be accountable for assigned actions and results.
Develop an in-depth knowledge of global governmental pharmacovigilance regulations that impact the research, development and marketing of medicines and devices as well as relevant Company policies and procedures associated with GVP. Within the area of expertise, maintains awareness of industry trends and developments.
Partner with management of PV Compliance and Inspection Readiness organization to proactively identify opportunities for process improvement to increase the effectiveness and efficiency of the WWPS organization.
As appropriate, partner with WWPS and service provider personnel to resolve quality issues as well as to optimize processes for reliability, effectiveness and efficiency.
Demonstrated effective oral/written communication and strong interpersonal relationship skills for the recommendations for quality improvements of key CAPA and inspection readiness deliverables to our internal and external customers.
Serves as a source of information pertaining to global safety regulations for internal and external customers involved in Global Pharmacovigilance activities.
Demonstrated an understanding the following:
Microsoft Office Suite
Corporate Safety Database
Web-based employee time tracking
Document management system for authoring, reviewing, and approving electronic documentation (i.E., SharePoint, Docbase, etc.)
Corporate learning management system
Corporate Quality Management System
Office communication tools including but not limited to company email, copy machines, and scanners.
Prior experience with providing guidance to senior management on regulatory and compliance issues germane to pharmacovigilance preferred.
Experienced or certified in project management preferred.
Project Description:
The WorldWide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.
Provides management for the investigation of Good Pharmacovigilance (GVP) related deviations to determine root cause and applicable corrective and preventive actions (CAPA) in accordance with applicable global health authority regulations and company standards.
Collaborate with WorldWide Patient Safety (WWPS) and internal stakeholders/subject matter expert resources to collect relevant information for deviation assessment and facilitate meetings with investigation teams.
Manage deviation records and monitor completion of corrective actions within the CORPORATION electronic Quality Management System.
Collaborate with colleagues for the collection and distribution of metrics associated with the GVP deviations program.
As necessary, function as a trainer for the GVP Deviations program to ensure WWPS stakeholders have an adequate understanding of the decision process.
Leads and supports the individual assessments for the identification, risk assessment, investigation, and closure of GVP deviations for issues impacting the GVP system.
Additionally, may contribute to the suggested remediation efforts.
Effectively collaborates with CORPORATION quality and compliance organizations (i.E., Global Quality) to maintain high standards of quality for the department.
Gathers information to contribute to the metrics supporting the Pharmacovigilance quality management system and, as necessary, the Pharmacovigilance Quality governance by reporting issues pertaining to deviations to senior WWPS leadership.
Manages the trending and analysis of quality issues from various sources for items impacting compliance and quality.
Concisely summarizes and effectively communicates the result of analysis and intelligence with stakeholders as appropriate to address issues and prevent reoccurrence of quality and compliance issues.
Ensures adequate oversight over scheduling and milestones for deviation investigations and associated trending.
Escalated any concerns over scheduling to area management.
Suggest improvements to the review of departmental standard operating procedures related to deviations to the GVP QMS.
Ensure all data supporting deviations and open CAPA within the Pharmacovigilance System Masterfile (PSMF) is current and of high quality to enable applicable sections to be generated in a timely manner.
Escalates issues to respective functions and management for evaluation and remediation.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Cindi: cindi@alphaconsulting.Com
ALPHA'S REQUIREMENT #23-00895
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
