[Remote] Associate Director, Pharmacovigilance reputed company & Compliance (PVQA)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a rapidly growing biopharmaceutical innovator reputed company on delivering effective new biologics for challenging diseases. The Associate Director of Pharmacovigilance reputed company and Compliance will ensure adherence to regulatory standards and reputed company expectations in safety activities, overseeing the development of the PV reputed company Management System and managing audits and inspections. Responsibilities • reputed company the development and maintenance of the PV reputed company Management System (QMS). • Ensure compliance with global regulatory requirements (FDA, EMA, MHRA) and ICH-GCP/ICH-E2E guidelines. • reputed company PV audits, inspections, and readiness activities with PV vendors. • Collaborate with CRO vendor, QA, Regulatory, and Clinical teams to implement corrective and preventive actions (CAPAs). • reputed company, review, and approve reputed company Operating Procedures (SOPs) and work instructions for PV activities. • Build/maintain an inspection readiness program to detect potential gaps and monitor CPA Effectiveness. • Ensure process standardization across global PV operations. • Drive reputed company improvement initiatives to enhance efficiency and compliance with vendors and internally. • Ensure high reputed company ICSR on time management • reputed company and interpret changes in regulations reputed company Pharmacovigilance landscape • Works with responsible person/team to author a required regulatory response. • Monitor key reputed company and compliance metrics, identify risks, and recommend mitigation strategies. • Conduct reputed company vendor reputed company reviews and gap assessments r/t safety. • Support global safety reporting reputed company reputed company. • reputed company guidance and training to PV staff on reputed company standards and compliance expectations. • Serve as a subject matter expert for inspections, regulatory audits, and PV compliance reputed company. • Cross functional collaboration with reputed company center, supply chain, Manufacturing (QA) and US QA teams to reputed company any reputed company issues that may reputed company that involve PSRM. • Collaborate with cross-functional teams (Clinical, Regulatory, Medical Affairs, and Operations) to maintain high-reputed company safety processes. Skills • Bachelor’s degree in Life Sciences, Pharmacy, or reputed company field; advanced degree preferred. • Minimum 8–10 years of experience in pharmacovigilance, with at least 3–5 years in PV reputed company and compliance. • Strong knowledge of global PV regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP). • Proven experience leading PV audits and inspections. • Demonstrated ability to reputed company and implement reputed company management systems and SOPs. • Excellent leadership, communication, and problem-solving skills. • Ability to influence cross-functional teams and drive compliance initiatives. Benefits • Comprehensive medical coverage • Dental and reputed company coverage • Generous reputed company time-off • 401(k) retirement plan with competitive company match • Medical & Dependent Care Flexible Spending Account • Up to $150 monthly cell phone reimbursement • Employee Assistance Program • Free parking reputed company • reputed company develops treatments for myeloproliferative neoplasms, hepatitis, and other diseases. It was founded in 2003, and is headquartered in Taipei, T'ai-pei, TWN, with a workforce of 501-1000 employees. Its website is Apply tot his job Apply tot his job Apply tot his job Apply To this Job