Job Title

A pharmaceutical company in New Jersey is looking to add a new Senior Pharmacovigilance Associate to their growing team. In this role, the Senior Pharmacovigilance Associate will be responsible for monitoring, processing, controlling, and reporting individual case safety reports and aggregate safety reports for company products.Responsibilities:The Senior Pharmacovigilance Associate will:Review individual case safety reports (ICSR) ensuring that adverse event reports are processed in a timely manner, in accordance with the appropriate company SOPs, study protocols, and within regulatory timelinesAssist with data-lock reconciliations and ensure all cases are complete and all outstanding queries are resolved and closedProvide pharmacovigilance input on essential study documentation from (study protocols, clinical trial agreement, safety management plan, clinical trial agreement, informed consent form, case report forms, protocol amendments and study reports)Remain up to date on all appropriate current health authority regulations and guidancePerform reconciliations with business partners, and other local US and global teamsAssist with pharmacovigilance processes, supporting preparation of SOPs, compiling data for FDA aggregate report submissionAuthor or review FDA aggregate safety reports such as periodic adverse drug experience reports (PADERs) along with the cover letterResearch and draft responses to inquiries from patients, healthcare professionals, and internal stakeholders in the form of FAQs and Standard Response teract with other departments and as needed on pharmacovigilance mattersPreparereview SOP, WI ? ICSR processing for Clinical trial casesQualifications:RPh, Pharm.D, RN or related degree in a Scientific fieldKnowledge of safety concepts, per ICH and FDA guidelines per device safety reporting requirementsIn-depth knowledge of the Drug Development process, Signal Detection, and Regulatory AffairsIn-depth knowledge of Domestic and Global Safety regulationsProfound knowledge of Scientific, Medical, and Clinical Research terminology, such as MedDRA codingSound knowledge of Microsoft Office applications, Outlook MailCalendar.Great interpersonal skillsExcellent communication skills (written and verbal)Strong attention to detailHighly organizedDesired Skills:2+ years of experience within a Pharmaceutical, CRO, or Healthcare environment