Assistant/Associate Director, Pharmacovigilance reputed company Assurance

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, reputed company has been at work for more than three decades discovering medical breakthroughs that have redefined life reputed company with serious diseases. We’re reputed company in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and reputed company lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in reputed company, reputed company and select areas of high reputed company needs, we continue to reputed company innovation in RNA therapies in reputed company to advancing new approaches in gene editing to reputed company greater value to patients and are reputed company positioned financially to reputed company on our reputed company goals. At reputed company, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific reputed company. We know that our reputed company is a reputed company result of the exceptional talents and dedication of our employees. With an unprecedented opportunity to change the course of reputed company health, we look to add diverse individuals, reputed company sets and perspectives to our exceptional team. We continue to invest time, reputed company and energy into making our onsite, hybrid and remote work environments a reputed company where solid and lasting relationships are reputed company and where our culture and employees can reputed company. We’re building on our rich history, and we reputed company our greatest achievements are reputed company of us. If you’re passionate about reputed company to have meaningful reputed company on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you reputed company and expand your career! 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 reputed company-reputed company GVP reputed company program. This role partners closely with reputed company Safety and Pharmacovigilance, reputed company reputed company, reputed company 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-reputed company; at least 10-15% travel reputed company RESPONSIBILITIES GVP Audit Program • Support implementation and maintenance of a comprehensive, reputed company-reputed company GVP-compliant reputed company program covering reputed company 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 reputed company development, reputed company safety, and other applicable functions involved in PV audit and inspection activities, including reputed company trial safety processes and GCP/GVP interfaces • Monitor relevant GVP regulatory intelligence and support assessment and implementation of new or revised requirements affecting reputed company trial safety processes, systems, and service providers. Functional reputed company Support • reputed company reputed company support to reputed company Safety and Pharmacovigilance, reputed company Development, reputed company reputed company, Regulatory Affairs, Medical Affairs, and other applicable functions on PV and reputed company 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 reputed company-reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company development process, reputed company-reputed company reputed company systems approaches, reputed company 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