APCER Life Sciences, Inc. is seeking a Manager Pharmacovigilance, Client Site Operations for its Jersey City, NJ office.Job Duties: Conduct research using bioinformatics theory and methods in pharmacovigilance. Act as the Company liaison for the Client, APCER and APCER affiliates regarding safety data project expectations, training, quality, compliance, and delivery. Work in partnership with client and internal and external contacts to achieve project-specific and ad-hoc deliverables. Participate in internal and external audits, responding to any quality issues identified. Support Pharmacovigilance Inspections and Health Authority requests. Maintain knowledge of applicable regulatory legislation, guidelines and regulations pertaining to safety reporting. Ensure team compliance to Standard Operating Procedures (SOP), Operational Guides (OG), Policies and Safety Management Plans. Manage project related budgets to ensure expenditures do not exceed agreements. Supports Project Management regarding new initiatives, resourcing, and deliverables. Conducts training programs for APCER internal departments and new hires. Support technology related projects such as safety database upgrades, implementation of new ICSR processing and intake tools. Work on safety database like ARGUS and tools like Global Intake tool (GIT), Quadrant.Minimum Requirements: Must have a bachelor’s degree in Pharmaceutical Science or a related field (or foreign degree equivalent) and five years of experience as a Pharmacovigilance associate or related.Experience must include: Five (5) years of experience of ICSR processing in pharmacovigilance safety databases performing initial case assessment for seriousness, causality and expectedness for regulatory reporting.Five (5) years of experience utilizing medical and scientific knowledge in determining suspect medications and coding of events using MedDRA and WHO dictionary.Five (5) years of experience drafting and drafting of SOP, SMPs, OG communications plans.One (1) year of experience as the company liaison for the Client, APCER and APCER affiliates with regards to safety data project expectations, training, quality, compliance, and delivery.Two (2) years of experience managing post marketed and clinical trial products Individual Case Processing (ICSRs) workflow distribution, prioritization, and work progress to ensure compliance with regulatory guidelines and meet client deliverables.Job Order number must be indicated on your response. Please send résumé to:Job # 202403APCER Life Sciences, Inc.Attn: Carolann Kubik111 Town Square PlaceSuite 860Jersey City, NJ 07310or UsJobs@apcerls.com$151,648 to $153,000. Benefits: medical, dental, vision, life, 401K, FSA and HSA, vacation and paid holidays.