Manager, Drug Safety & PV Compliance

About Currax

Currax Pharmaceuticals LLC is a specialty pharmaceuticals company focused on providing increased access to life-changing medications for patients and healthcare providers. We seek to improve patient health and quality of life through the acquisition and commercialization of medications, including Contrave, Silenor, Treximet, ONZETRA Xsail, and a portfolio of generic medications.

At Currax, we take pride in our mission to serve patients, and we value authenticity and collaboration in our workplace. As we experience an exciting period of accelerated growth, our organization is rich with opportunities for our people to gain hands-on experience and fulfill career aspirations while making a direct impact on the lives of patients we serve.

About the Role

The Manager, Drug Safety PV Compliance performs operational tasks and activities supporting the Pharmacovigilance & Drug Safety organization. Reporting to the Director, Drug Safety and Pharmacovigilance.

The Manager, Drug Safety PV Compliance will be a key contributor in growing and shaping Currax's global Pharmacovigilance Drug Safety Compliance Program (GCP/GLP/GVP). Primarily focusing on PV drug safety, the PV compliance manager will assist and contribute to building PV presence globally, aid in the establishment and execution of PV compliance strategy while appropriately collaborating with Quality in support of Currax's inspection readiness activities both locally and globally, support Health Authorities Inspections (e.g., MHRA, EMA etc.), and provide Pharmacovigilance compliance support of Quality audit programs (e.g., Affiliate/ Vendor/Process Audits, etc.) and partner with R&D Quality (RDQ) Program Leads.

This role will also support other GxP disciplines (GCP, GLP, and CSV) and contributions to Regulatory Intelligence activities. The appointee will proactively partner with local and global operational functions and teams (Clinical, Marketing, Regulatory, Corporate Compliance & Quality) to create a collaborative culture within Currax and help reach a sustained state of inspection readiness and PV compliance.

Responsibilities

• Participate in Regulatory Authority inspections (GVP, GCP, GLP) including inspection preparation training and support; actively support during PV inspection and provide input and review of responses to inspection observations and regulatory agency questions.
• Proactively partner with members of global and regional Research and Development functions and teams to support the successful execution and ensure PV compliance of R&D activities.
• Develop and/or provide input in the development of PV and Quality Audit Schedules and Annual Audit Plans.
• Provide QA with PV consultation support for CSPV, RA and Medical Affairs/ Medical Information
• Assist in the strategic direction for the global and regional program for PV audits (e.g., Affiliate/ Vendor/Process Audits, etc.) that integrate into the global R&D program and manage the program utilizing an innovative, risk-based approach.
• Participate in complex PV audits including planning, execution, reporting, and providing guidance to Currax staff to ensure the proposed corrective actions received from the auditees are appropriate.
• Assist in the management of CAPA requests to and from global business partners. Support any deviations and CAPA management, including collaboration with SMEs to collect and track the receipt of objective evidence to support Deviations & CAPAs
• Provide leadership to interdisciplinary audit teams for complex systems/process audits.
• Proactively identify and report systematic PV issues as well as opportunities for process improvements.
• Provide support, education, guidance and/or training for PV & Quality functional areas regarding PV compliance and QA projects and initiatives.
• Contribute to the continuing development of an efficient PV compliance culture at Currax
• Appropriately manage uploads and tracking of PV documents in the quality document management system
• Support and develop PSMF documentation, reporting and metrics
• Track and follow up on PV initiatives/compliance metrics with internal key stakeholders in PV activities/processes
• Participate in the development and updating of Drug Safety curricula and training program
• Responsible for oversight of PV training compliance
• Support and understand call center activities to ensure quality standards are being upheld in a compliant manner and ensure the call center staff are appropriately trained on processes.
• Work with contract services vendors on activities related to quality metrics of the safety database

Required Qualification & Skills

• Bachelor's degree required
• 5=7+ years' experience in relevant Pharmaceutical, Biotech or Clinical Research Organization industry experience in a global environment
• Strong knowledge of relevant FDA, EU, ICH Pharmacovigilance guidelines and GVP regulations and local legislation.
• Experience working with CROs, vendors, and relationship management preferred.
• Strong auditing and compliance skills with experience in communicating significant observations to internal and external business partners in a sound and factual manner.
• Demonstrated ability to build relationships, work and collaborate effectively with cross-functional areas and lead cross functions projects
• Strong leadership skills with ability to effectively organize and execute tasks.
• Excellent analytical, problem solving and decision-making skills in a complex, fast-paced, changing environment with strong communication and presentation skills, both verbal and written
• Excellent communication and presentation skills, both verbal and written.
• Ability to influence and negotiate effective solutions, excellent interpersonal skills.
• Ability to manage multiple projects in a fast-paced environment with good time management skills.

• Willing to travel ~25%

Currax Core Values

• Integrity
• Passion
• Accountability
• Commitment
• Teamwork

Currax is committed to the health and well-being of our employees and families and offers a comprehensive benefits package. Available benefits include medical, dental, and vision coverage, 401(k) plan with company match, paid time off and holidays, and other benefits to support your physical, financial, and social well-being.

Currax Pharmaceuticals LLC does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact Human Resources at human.resources@curraxpharma.com Read our full EEO statement at

http://www.curraxpharma.com/careers/eeo-statement/