Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, passionate people who thrive in a collaborative team environment.
If you’re looking to make a significant difference with a patient-centric company, then we invite you to learn more about the opportunities available at Veloxis.
Compensation and Benefits
Our success is tied to the contribution of every team member, which is why we provide a valuable, competitive compensation package that includes health and insurance benefits, training and development opportunities, as well as stock warrant grants and performance-based bonus eligibility.
We currently have a Sr. Manager, Pharmacovigilance position available in Cary, NC.
Purpose and Scope:
This is a very hands-on role since it is the sole pharmacovigilance position within the Company. The position is primarily responsible for the management, planning and execution of post-marketing and clinical safety activities, with additional responsibilities for regulatory operations and submissions. The incumbent in this position also serves as the primary product safety liaison with the Company’s license partners and the contract safety organization responsible for global pharmacovigilance.
Summary of Key Responsibilities:
- Develop and manage pharmacovigilance activities with the Company’s license partners
- 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 SAE processing by outsourced vendor, including the review and monitoring of compliance through various monitoring reports / KPIs;
- Participation in the in-line quality review of SAEs following vendor data entry, with a specific focus on accuracy of narrative to reflect source documentation, MedDRA coding, expectedness against local RSI and appropriateness of queries to seek follow up from the clinical sites / reporter;
- Review and approval of safety-related section of aggregate reports (PSUR, PADER, RMPs);
- Collaboration with vendor to development process-related documents for the purposes of improvement and standardization of new processes; and
- Maintaining knowledge of safety systems (Argus experience preferred)
- Create and maintain standard operations procedures and working practices to ensure inspection readiness and compliance with regulations and guidelines
- Support internal / external audits and regulatory inspections
- Manage pharmacovigilance budget and forecasting activities
- Facilitate internal safety review committee meetings
- Assist management in establishing and coordinating all product safety functions in accordance with regulations and the Company’s policies and procedures
- Prepare and review regulatory submissions, such as safety reports and IND / NDA annual reports
- Represent the Company in product safety meetings with its license partners and the contract safety organization
- Provide training to Company personnel for pharmacovigilance requirements and compliance
- Maintain current knowledge of regulations and regulatory guidelines, particularly in the US and Europe
Required Qualifications and Skills:
- Bachelor’s Degree in a scientific / technical discipline, RN or equivalent healthcare experience
- At least 5 years’ drug safety experience in the pharmaceutical industry
- Strong knowledge of US and EU pharmacovigilance regulatory requirements and current pharmacovigilance practices
- Solid experience with drug safety databases, especially with Argus
- Solid vendor management experience
- Self-motivated, detail-oriented, with the ability to prioritize and plan effectively
- Excellent written and verbal communication skills
- Ability to work in a dynamic, fast-paced environment with shirting priorities
- Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Pro
Please send cover letter and resume to email@example.com
Equal Opportunity Employer
Veloxis is an equal opportunity employer that welcomes candidates with diverse backgrounds. Applicants are considered on the basis of their qualifications, without regard to race, color, religion, sex (including pregnancy and gender identity), national origin, age, disability, genetic information, veteran status, and other protected class characteristics protected by state, local, or municipal law.