Manager, Pharmacovigilance (PV) Standards, Quality, Training & Compliance

Purdue Pharma L.P. and its subsidiaries develop, manufacture and market medications to meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians, and we are currently led by a physician. Beyond our efforts to provide quality medications, Purdue is committed to supporting national, regional and local collaborations to drive innovations in patient care. Privately held, Purdue is pursuing a pipeline of new medications through internal research & development and strategic industry partnerships.

For close to two decades Purdue has engaged in many initiatives to stem prescription opioid abuse. We are committed to bringing lifesaving relief to communities and individuals suffering from substance use disorder and overdose. We are currently developing or supporting the development of two essential life-saving opioid overdose reversal medications and have the capability to manufacture others for medication assisted treatment. Providing these medicines has the potential to improve and save countless lives.

We are driven by our purpose: Compassion for patients and excellence for science inspire our pursuit of new medicines.

We are building an exciting path forward, and we are committed to recruiting a dedicated team of professionals who advance our expertise through a commitment to Purdue's Values: Integrity and Courage, underpinned by Innovation, and always in Collaboration with each other.

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 strive to create an environment where you can bring your best to work each day. We welcome the opportunity to have you on our team!

Job Summary

Responsible for ensuring the Company's global pharmacovigilance (PV) system remains compliant with legal and regulatory requirements as both a Marketing Authorization Holder and a Clinical Trial Sponsor. Develop and deliver PV specific training, maintain systems to track and oversee compliance, monitor PV system performance, ensure timely and effective CAPA implementation, and support the development and maintenance of compliant procedures within the Quality Management System (QMS).

Primary Responsibilities

• Conduct regular gap analysis of the Company's PV system to ensure ongoing compliance with global regulatory pharmacovigilance requirements.
• Develop and propose new PV procedures, or IT systems and manage updates to existing ones as needed.
• Manage commitments with license partners to ensure mutual compliance with aggregate reporting requirements outlines in PV Agreements.
• Create, update, and implement PV in coordination with the Quality Department, ensuring timely rollout and related training.
• Oversee PV standards and procedures; ensure CAPAs are put in place and executed where needed.
• Develop systems - both procedural and electronic - to support oversight of the PV system, including KPI tracking and performance monitoring.
• Support internal and external PV audits and inspections, including preparations, participation and follow-up activities.
• Participate as an auditor in mock audits as needed.
• Provide input in annual PV Audit Plan and ensure ad-hoc updates are made as required.
• Review audit and inspection reports, identify areas in need of corrective and/or preventive actions, and ensure appropriate root cause analyses and CAPAs are documented and executed.
• Maintain 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 PV-related role-based training matrices; deliver PV training to organization and external vendors as requested.
• Ensure adequate documentation and proof of PV training for all relevant employees.
• Provide PV input into vendor and partner contractors (e.g. PSP, Market Research, social media screening projects, etc.) and maintain oversight of third-party compliance.
• Ensure that a living overview of such contracts is available to PV. Monitor compliance with third-party contracts, propose corrective or preventive actions as needed to restore or continue compliance.
• Oversee vendor performance and manage case medical review activities according to internal timelines.
• Support the team in monitoring changes and new developments to global regulatory pharmacovigilance requirements.
• Provide support in signaling, assessing and implementing the potential impact of such changes and new developments on the Company's PV system.
• Act as back-up for Vendor operations, assist with quality control of outsourced activities, and develop relevant operational metrics.
• Other duties as assigned.

Education and Experience Requirements

• Bachelor's degree in healthcare or life sciences required; Advanced degree, such as PharmD, RN or BSN highly desirable
• 5+ years of experience in pharmacovigilance quality and compliance monitoring; 3-4 years of direct experience in Pharmacovigilance Compliance, global setting preferred

Necessary Knowledge, Skills, and Abilities

• Strong knowledge of Food and Drug Administration (FDA), European Union (EU), and International Conference on Harmonization (ICH) guidelines
• Excellent verbal, written and interpersonal communication skills
• Ability to effectively problem solve and implement solutions
• Demonstrated good judgment with 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 work culture and work constructively and collaboratively under pressure; Ability to work cross-functionally, build relationships and quickly gain credibility with business leaders

Supervisory Responsibilities (if Applicable)

N/A

We are an Equal Opportunity Employer. Qualified applicants will receive consideration without regard to: actual or perceived race, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), national origin, ancestry, citizenship status, religion, color, age, creed, sexual orientation, marital status, gender identity or gender expression (including transgender status), protected medical condition as defined by applicable state or local law, genetic information, physical or mental disability, veteran status and military service, or any other characteristic protected by local, state, or federal laws and ordinance.

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Under certain state law, we may be required to provide a reasonable estimate of the salary range for the jobs covered by this description. Actual salary determinations will take into account factors such as work location, prior education or training and experience, job related knowledge, and demonstrated skills aligned with the Company's internal leveling guidelines and benchmarks. Resumes may be considered in the order they are received.