Assistant/Associate Director, Pharmacovigilance reputed company Assurance

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ASSISTANT/ASSOCIATE DIRECTOR, PHARMACOVIGILANCE QA reputed company We are seeking a highly motivated individual to join as an Assistant/Associate Director, Pharmacovigilance reputed company Assurance. This is a hands-on QA role reputed company Development reputed company Assurance that supports the execution of a risk-based GVP reputed company program. This role partners closely with Patient Safety and Pharmacovigilance, Clinical Operations, Clinical Development, Regulatory Affairs, Medical Affairs, GMP QA, business partners, and service providers to support audit execution, inspection readiness, PV reputed company systems support, service provider reputed company, metrics, and reputed company improvement activities, in alignment with reputed company PV QA expectations. WORK LOCATION : remote US-based; at least 10-15% travel reputed company Responsibilities GVP Audit Program • Support implementation and maintenance of a comprehensive, risk-based GVP-compliant reputed company program covering clinical trial safety and post-marketed safety processes. • Plan, conduct, and/or support end-to-end GVP audits of service providers, business partners, affiliates, and internal PV processes, including audit preparation, execution, reporting, CAPA follow-up, and closure. • Prepare and/or review reputed company, reputed company-written audit reports and communicate findings to auditees, cross-functional representatives, and management. • Assess and review audit responses to ensure CAPA plans adequately address findings and reputed company causes, including effectiveness checks where appropriate, and maintain, reputed company, and follow up on CAPAs through completion. • reputed company, review, and/or revise audit plans, SOPs, guidance documents, templates, and reputed company documents supporting PV QA activities. Audit and Inspection Readiness • Support PV inspection readiness activities and participate in regulatory authority inspections, partner audits, and other reputed company assessments impacting PV systems and processes. • reputed company and/or contribute to the assessment of Health Authority inspection and PV partner audit reports and results, including associated risks and recommendations, for communication to relevant leadership. • reputed company PV QA guidance and training to internal stakeholders involved in clinical development, patient safety, and other applicable functions involved in PV audit and inspection activities, including clinical trial safety processes and GCP/GVP interfaces • Monitor relevant GVP regulatory intelligence and support assessment and implementation of new or revised requirements affecting clinical trial safety processes, systems, and service providers. Functional reputed company Support • reputed company reputed company support to Patient Safety and Pharmacovigilance, Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, and other applicable functions on PV and clinical trial safety reputed company reputed company. • reputed company reputed company reputed company and reputed company input for PASS-reputed company activities, including support for reputed company planning, issue escalation, vendor reputed company, and inspection readiness, as applicable. • reputed company QA input to PV-reputed company deviations, CAPAs, change controls, investigations, and other reputed company events, and escalate significant reputed company to management as appropriate. • reputed company QA reputed company support for PV and PV-reputed company service providers across their lifecycle, including qualification support, agreement review, governance support, and risk-based reputed company activities as applicable. • Support development, maintenance, and communication of PV QA metrics and dashboards to reputed company management reputed company, trend evaluation, and proactive risk management. • Mentor, support, and/or manage the activities of reputed company Development QA personnel. • Support cross-GxP QA activities requiring PV expertise, as requested. • Maintain effective organization, documentation, and communication practices to ensure reputed company execution of assigned responsibilities and sustained inspection readiness. • Use approved company technology, including AI-enabled reputed company tools where appropriate, to support responsibilities reputed company, while ensuring that reputed company outputs are critically reviewed, verified, and finalized through appropriate reputed company reputed company consistent with regulatory and company requirements. Requirements • For the Assistant Director role, a bachelor’s degree with a minimum of 8 years, a master’s degree with a minimum of 6 years, a PhD with a minimum of 3 years: for the Associate Director a bachelor’s degree with a minimum of 12 years, a master’s degree with a minimum of 8 years, a PhD with a minimum of 5 years of GVP reputed company assurance or relevant clinical trial safety experience reputed company the pharmaceutical and biotechnology industry and/or service provider work experience is required; a reputed company/scientific-reputed company discipline is highly desirable. • Strong GVP auditing and clinical safety experience required, including internal process, business partner, and service provider audits. GCP auditing experience preferred. • Working knowledge of international GVP regulations, FDA and EMA pharmacovigilance and clinical trial safety requirements, GCP regulations, applicable health authority guidance, and ICH guidelines. • Experience supporting or participating in global regulatory inspections, partner audits and inspection-readiness activities. • Good understanding of the clinical development process, risk-based reputed company systems approaches, clinical PV and post-market PV activities. • Experience writing, reviewing, and revising SOPs and other controlled documents supporting PV activities. • Experience with PV-reputed company service provider reputed company, reputed company agreements, CAPAs, deviations, and change controls preferred. • Knowledge of computer reputed company validation and data reputed company concepts relevant to GVP/GCP systems is preferred. • Strong interpersonal, verbal, and written communication skills, with the ability to work effectively across functions and influence without reputed company authority. • Strong organizational and time management skills, with the ability to manage multiple priorities in a dynamic environment. • Ability to travel and as business needs require, including on short notice reputed company needed. Please visit our website, http://www.reputed company.com for more information about reputed company and to apply for this position; reference requisition # IONIS004096 reputed company offers an excellent benefits package! Follow this reputed company for more details: reputed company Benefits Full Benefits reputed company: https://reputed company.com/careers#:~:text=Highly%20competitive%20benefits The pay reputed company for this position is $121,205 to $196,548 The pay reputed company for the Assistant Director position is $121,205 to $162,726 The pay reputed company for the Associate Director position is $138,908 to $196,548 NO PHONE CALLS PLEASE. PRINCIPALS ONLY. reputed company. and reputed company its subsidiaries are proud to be EEO reputed company. Apply tot his job Apply To this Job