Duties: Scope of Role Responsible for supporting the Pharmacovigilance (PV) database maintenance. Responsible for supporting and performing PV database data retrieval activities.
Primary Responsibilities: • Execution of weekly, monthly and ad hoc reports from the PV database • Preform all required Quality Control (QC) and complete documentation • Assist with the execution and verification of Ethics Committee and Health Authority Periodic outputs • Maintain and distribute the Study Configuration Spreadsheet • Maintain and distribute applicable sections of the Data Entry Conventions and associated appendices • Track the development, testing, implementation and closure of all PV Systems requests • Assist PV Systems Director with the following activities: • maintenance and delivery of systems supporting the PV business unit, the primary focus is the Argus Safety Systems. • monitoring of PV System vendor activities and ensuring compliance with contractual expectations • maintaining documentation of system configuration and all subsequent changes • validates and implements annual, periodic and ad-hoc reports in the Drug Safety systems • maintaining the processes for systems in compliance with regulatory requirements and company standards
Skills: Education/Experience/Skills • At least 4 years of experience in Pharmacovigilance Systems with at least 2 years of experience with data retrieval from the Oracle Argus Safety Database • Attention to detail, Critical thinking, Creative problem-solving, Collaborative approach, Proficient Computer Skills, including Microsoft Word and Excel • Knowledge of Drug Safety and Pharmacovigilance function
Education: At least 4 years of experience in Pharmacovigilance Systems with at least 2 years of experience with data retrieval from the Oracle Argus Safety Database
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $50.00/hr.
