Manager, Pharmacovigilance Vendor Oversight & Compliance
and its subsidiaries develop, manufacture and market medications and consumer health products to meet the evolving needs of healthcare professionals, patients, consumers and caregivers.
At Purdue Pharma and our subsidiaries, you have a unique career opportunity to work differently, uncover and seize new opportunities, and take a hands-on, ownership approach to your work. We go beyond traditional roles and find creative ways to extend our skills and interests, challenging ourselves to contribute in different, meaningful ways. We welcome the opportunity to have you on our team!
Our Commitment to Diversity, Equity, Inclusion and Belonging
We are driven by our purpose: Compassion for patients and excellence for science inspire our pursuit of new medicines.
Diversity, Equity, Inclusion and Belonging are important to our business and are articulated in our People and Culture strategy and represent an important component of our goals and objectives. As we build an exciting path forward, we strive to create an environment where everyone can bring their best and true self to work each day. Embracing different backgrounds, ideas, and viewpoints are valued and encouraged. We believe that Respect is grounded in our Values of Integrity and Courage, underpinned by Innovation, and always in Collaboration with each other. Together we make an impact on our growth, our culture, and most importantly, patients.
The Manager, Pharmacovigilance (PV) Vendor Oversight will partner with the Purdue DSP team, and vendor to provide US PV expertise. The Manager, PV Vendor Oversight and Compliance will also be responsible for assisting PV leadership to provide oversight for DSP vendor activities in accordance with sponsor oversight regulatory requirements. PV Standards, Training & Compliance is a business area expert supporting the Executive Director, Safety Operations, Standards and Compliance in establishing procedures and processes to ensure the overall compliance of the company-wide pharmacovigilance system with Purdue’s legal PV obligations both as Marketing Authorization Holder and Sponsor of clinical trials.
This is achieved by developing and delivering PV specific training for Purdue personnel and key vendors; developing and maintaining systems to oversee and track compliance with pharmacovigilance regulatory requirements, including oversight of system performance, assurance that adequate CAPA plans are installed where needed and are timely completed; provide support to the development of written procedures to ensure that the PV system is compliant with governing regulations and adequately described in Quality Management System documents.
- Perform regular gap analysis of the Purdue pharmacovigilance system to ensure ongoing compliance with regulatory pharmacovigilance requirements globally.
- Oversee functional specifications of any data requirements for aggregate deliverables from the safety database, cross-functional team.
- Manage distribution of assignments and prioritization of tasks within the DSP operations aggregate reporting team
- Provide vendor oversight and manage medical review of cases according to internal timelines
- Manages commitments with license partners to ensure both meet aggregate reporting requirements as per the PV Agreement between companies
- Prepare proposals for the development of new PV specific procedures or IT systems, or for changes in existing ones as needed.
- Where gaps in the quality management system exist or updates are needed, ensure continued compliance with regulatory pharmacovigilance requirements globally.
- In cooperation with Purdue’s Quality Department also author new pharmacovigilance procedures or updates thereof, ensure their timely release, related training requirements and their implementation.
- Ensure oversight of the applied PV procedures and standards; ensure CAPAs are put in place where needed and are executed.
- Build systems (procedural and electronic) to facilitate oversight by the Executive Director and Head of Safety Operations of the PV system and its functioning and for monitoring ongoing compliance with all applicable regulatory pharmacovigilance requirements globally. Develop additional KPIs where needed to ensure proper overview of the system’s performance.
- Support the preparation for and management of PV related audits (internal and of key Purdue vendors and business partners) and Authority inspections. Participate in such audits as auditor as needed and provide support to pharmacovigilance inspections; participate as interviewee in such inspections as needed.
- Provide input in Purdue’s annual PV Audit Plan and ensure ad-hoc updates are made should these become needed.
- Receive and review reports on internal and external PV specific and non-PV specific audits and inspections and identify areas needing corrective and/or preventive actions. Ensure adequate root cause analysis is available and well documented to cover pharmacovigilance aspects.
- Maintain the audit trail of CAPA plans with PV relevance and create living overview of their status of executional progression and completion. Escalate overdue CAPAs or CAPAs at risk to the Executive Director and Head of Safety Operations.
- Advise on role specific training matrices for Purdue personnel from a pharmacovigilance perspective.
- Deliver PV training to Purdue Personnel and, on request also to service providers (Purdue vendors) and business partners. Ensure proof is available of adequate and continued fulfilment of PV training requirements for all Purdue Personnel.
- Provide input into PV requirements and clauses necessary to be included in contracts with service providers (Purdue vendors) for PV specific and other services (for instance vendors to whom management of PSP is potentially outsourced or who are supporting Market Research, social media screening projects or other), as well as in contracts with business partners and investigators in investigator sponsored clinical trials that are supported by Purdue.
- Ensure that a living overview of such contracts is available to PV and monitor compliance of the third parties with the clauses in the contracts, propose corrective or preventive actions where needed to restore compliance or assure continued compliance.
- Support the Executive Director and Head of Safety Operations in the monitoring of changes and new developments in the regulatory pharmacovigilance requirements globally.
- Provide support in signaling, assessing, and implementing the potential impact of such changes and new developments on Purdue’s PV system.
Education and Experience:
- Bachelor’s or higher degree in healthcare or life sciences
- An advanced degree such as MD, PharmD, RN or BSN is preferred
- 5+ years of experience in pharmacovigilance quality and compliance monitoring
- 3-4 years of direct experience in Pharmacovigilance Compliance, global setting preferred
- Possesses strong knowledge of Food and Drug Administration (FDA), European Union (EU), and International Conference on Harmonization (ICH) guidelines
Necessary Knowledge, Skills and Abilities:
- Excellent verbal, written and interpersonal communication skills at all levels of the organization
- Experience with aggregate analysis and writing PSUR's, PADER’s and DSUR
- Problem solving and good clarity of judgment and effectiveness at implementation of solutions with the ability to influence without authority
- Critical and objective interpretation of business, scientific and commercial information
- Proven project management skills; good planning, analytical, and time management skills
- Ability to foster a strong, positive culture and works constructively under pressure
- Agility - can confidently gain credibility quickly with leaders across the organization
- Demonstrated ability to work cross-functionally with strong collaboration and relationship building skills will be critical to the success of this role
Our Company is an Equal Employment Opportunity/Affirmative Action employer, Minority/Female/Disability/Veteran, encouraging diversity in the workplace. Qualified applicants will receive consideration for employment without regard to their race, gender, national origin, religion, color, age, sex, sexual orientation, pregnancy, marital status, gender identity or expression, genetic information, disability, veteran or military status, or any other characteristic protected by local, state, or federal law.
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- Job Family Medical Affairs
- Pay Type Salary
- 201 Tresser Blvd, Stamford, CT 06901, USA