Drug Safety PV Specialist

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 Drug Safety & PV Specialist reports to the Director, Drug Safety & Pharmacovigilance and is primarily responsible for performing operational tasks and activities supporting the Pharmacovigilance & Drug Safety organization. The PV Specialist will be a key contributor in growing and shaping Currax's global Pharmacovigilance Drug Safety Inspection Readiness Program (GCP/GLP/GVP). The PV Specialist will assist and contribute to building PV presence globally, aid in the establishment and execution of PV operations and compliance strategy while appropriately collaborating with Quality in support of Currax inspection readiness activities for both locally and globally inspections (e.g., Health Authority Inspections - MHRA, EMA, FDA etc.). This role will proactively collaborate 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. Additionally focusing on PV Drug Safety, the PV Specialist will support the development and maintenance of the necessary processes to ensure high quality pharmacovigilance data capturing and reporting. This role will leverage knowledge of CFR, ICH, and EU PV legislation, MedDRA, and WHO-DD coding to ensure high quality of PV operations and inspection 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.
• 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
• Assist in complex PV audits including planning, execution, reporting, and collaborating with Currax staff to ensure the proposed corrective actions received from the auditees are appropriate
• Provide input in the development of PV and Quality Audit Schedules and Annual Audit Plans.
• Provide support, education, guidance and/or training for Quality and other functional areas regarding PV inspection readiness for on-site and remote inspections and audit.
• Assist in the management of CAPA requests to and from global business partners. Support any deviations and CAPA management, including collaboration with Subject Matter Experts (SMEs) to collect and track the receipt of objective evidence to support deviations & CAPAs.
• Contribute to the continuing development of an efficient inspection readiness PV culture at Currax
• Support global case management in reconciliation activities, monthly testing (email, phone & fax) of PV vendor and filing/archiving of DSPV documents.
• Execute the compilation of Monthly Report Summary forms with non-EU external business partners
• Participate in the development and updating of PV System policies, SOPs, work instructions, forms and guidance documents to ensure compliance with all applicable regulatory requirements, guidelines, GVP and industry best practices
• Proactively identify and report systematic PV issues as well as opportunities for process improvements.
• Schedule meetings and record minutes for multiple DSPV projects
• Escalate issues to DSPV management as needed

Required Qualification & Skills

• Bachelor's degree preferably in life science, nursing, pharmacy and other health related profession
• Minimum of 3- 5+ of direct pharmacovigilance experience in Biotech, Pharma or Clinical Research Organization industry in a global environment.
• Knowledge of relevant FDA, EU, ICH, MHRA, and Health Canada pharmacovigilance guidelines and GVP regulations and local legislation.
• Experience working with CROs, vendors, and relationship management preferred.
• Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment.
• Detail-oriented, with good organizational, prioritization of competing requests/projects. And time management proficiencies. Must be able to work on multiple projects simultaneously and independently.
• Demonstrated ability to build relationships, work and collaborate effectively with cross-functional areas and lead cross functions projects.
• 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.
• Ability to influence and negotiate effective solutions, excellent interpersonal skills.
• Willing to travel ~15%

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 Pharmaceutical 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/