Safety Scientist-Pharmacovigilance, HCP | New Jersey

Job Description

Safety Scientist-Pharmacovigilance, HCP | New Jersey

Job Summary LOCATION: New Jersey DESIGNATION: Safety Scientist-Pharmacovigilance, HCP QUALIFICATION: To participate in adverse event case management, clinical management activities and evaluate AE reports to ensure drug safety. (1.) To assist with the preparation of adverse event reporting plans (AERPs), participate in quality assessment reviews, audits and engage in gap analysis for SOPs (2.) To be responsible for quality levels & revision rates of client to include all aspects of client revisions including running reports, completing/assigning revisions, compiling data, developing strategies to reduce revisions, mentoring staff on revisions, and communicating revision information to the client. (3.) To partner with Program Manager in communicating key issues & milestones to the stakeholders, and ensure that all internal and client-specific activities are performed in compliance with regulatory requirements. (4.) To perform literature review for identification of case reports & relevant safety information, prepare training materials specific to safety and mentor & train new/existing staff on client requirements. (5.) To process & evaluate AE reports according to the customer's standard operating procedures (SOPs), ensure quality & accuracy of data and assist in the reconciliation of clinical & safety databases. SKILLS: BSc EXPERIENCE: 3-5 Years NO. OF POSITIONS: Pharmacovigilance HCP View Job Details and Apply