Company:Veloxis Pharmaceuticals, Inc.
Job Description:This position is primarily responsible for providing management level oversight, planning and execution of post-marketing and clinical trial safety activities ensuring compliance, quality, inspection readiness and operational excellence. The incumbent in this position also serves as a safety liaison with the Company's cross-functional teams, license partners and the contract safety organizations responsible for global drug safety and pharmacovigilance.
The base compensation range for this role is $120-130K. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.
Summary of Key Responsibilities- Serve as resource and contact for other functions within the company for pharmacovigilance operational activities
- Responsible for overall vendor performance and vendor service outputs (delivered timely and on budget) including, but not limited to:
- Oversight of US AE call center;
- Oversight of adverse event processing by outsourced vendor, including the review and monitoring of compliance through various monitoring reports / KPIs;
- Participation in quality audits of individual case safety reports (ICSR) following vendor processing, with a specific focus on accuracy of narrative to reflect source documentation, MedDRA coding, expectedness against RSIs and appropriateness of queries to seek follow-up from the clinical sites / reporter;
- Oversight of adverse event reconciliation between safety and clinical databases, and adverse events exchanged between licensing partners;
- Review of safety-related section of aggregate reports (DSUR, PSUR/PBRER, PADER, RMP);
- Review and approval of pharmacovigilance related documents submitted to the Trial Master File (TMF);
- Provision of vendor project specific training;
- Collaboration with vendors to develop Safety Management Plans (SMP) and relevant forms and templates;
- Collaboration with vendors to develop process-related documents for the purposes of improvement and standardization of new processes; and
- Maintaining knowledge of safety systems (Argus experience preferred);
- Assist in creating and maintaining standard operating procedures and working practices to ensure inspection readiness and compliance with regulations and guidelines;
- Support internal / external audits and regulatory inspections;
- Assist in management of pharmacovigilance vendor contracts and forecasting activities;
- Assist in management of license partner safety data exchange agreements (SDEA);
- Assist management in establishing and coordinating all product safety operations functions in accordance with regulations and the Company's policies and procedures;
- Assist in preparation and review of regulatory submissions, such as safety reports and aggregate / periodic reports;
- Represent the Company in product safety meetings with its cross-functional teams, license partners and contract safety organization;
- Provide training to Company personnel and third parties for pharmacovigilance requirements and compliance;
- Maintain current knowledge of regulations and regulatory guidelines, particularly in the US, Europe and Japan.
Required Qualifications and Skills- Bachelor's degree in life sciences, nursing, pharmacy, or related healthcare profession with relevant experience
- At least 5 years of pharmaceutical industry drug safety and pharmacovigilance experience involving development and post-marketed products
- Solid vendor management or CRO pharmacovigilance project management experience, including safety management plan preparation, establishment of KPIs / metrics, and contract management
- Strong knowledge of ICSR processing and the adverse event lifecycle
- Solid experience with drug safety databases, especially with Argus; data migration experience preferred
- Ability to independently identify, analyze, and solve complex operational and data-related issues
- Strong understanding of current pharmacovigilance practices and global pharmacovigilance regulations, including regulatory reporting requirements
- Self-motivated, detail-oriented, with the ability to prioritize and plan effectively
- Excellent written and verbal communication skills
- Ability to work both independently and within a matrixed team in a dynamic, fast-paced environment with shifting priorities
- Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Pro
Travel Requirements: Approximately 10%
#LI-AS1 #Hybrid
