Manager, Global Drug Safety & Pharmacovigilance
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.
- 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
Recommended Jobs
Restoration/Reconstruction/Construction Project Manager
Job Description Job Description N-Tier Disaster Recovery Solutions (NTDRS) is seeking an experienced restoration/reconstruction Project Manager (PM) to manage projects from initiation to comple…
Shift Leader
Job Description Job Description Job Description Jersey Mike's Subs has been making amazing subs since 1956 in Point Pleasant New Jersey! The Jersey Mikes tradition was founded on a strong …
Registered Behavior Therapist_Joelton, Tennessee
Job Description Job Description Abilities Unlimited is currently hiring for a Registered Behavior Technician. Below is the details of the position: Position Overview: As a Registered Behavior…
Lounge Manager
Job Description Job Description We are looking for a Outlets Manager with open availability for our luxury boutique hotel in uptown Charlotte, NC. Outlets Supervisor Duties and Responsibilitie…
Youth Soccer Coach
Job Description Job Description Would you like to earn above-average pay while staying active and promoting life skills through SOCCER? Come join us at Soccer Stars! We are looking to hire an…
Superintendent (All Levels)
Job Description Job Description Salary: Our Company 35 North is a full-service program and project management firm that provides consulting, construction, cost, and commissioning solutions…
Quality Engineer (Systems & DLFT)
Job Description Job Description KEY RESPONSIBILITIES (other duties as assigned): ~ Responsible for trouble shooting root cause analysis, SPC data analysis, implementation and maintain up to dat…
Dressage Groom
Dressage Groom / Barn Professional: We are looking for a skilled, dependable Dressage Groom / Barn Professional to join our team. This is a hands-on role in a fast-paced, professional barn, best suit…
Travel Radiology Tech Interventional Radiology Tech Job
Job Description Are you a skilled Radiology Tech seeking an exciting Interventional Radiology Tech opportunity in beautiful Wilmington, North Carolina? This 13-week travel healthcare assignment off…
Plant Maintenance Manager
Maintenance Manager Summary: The Maintenance Manager will oversee all equipment for the plant. They will develop, implement and improve process control systems on all plant equipment. Maintena…