Job Description
Note:
The job is a remote job and is open to candidates in USA. PharmaEssentia USA is a rapidly growing biopharmaceutical innovator focused on delivering effective new biologics for challenging diseases. The Associate Director of Pharmacovigilance Quality and Compliance will ensure adherence to regulatory standards and quality expectations in safety activities, overseeing the development of the PV Quality Management System and managing audits and inspections. Responsibilities • Lead the development and maintenance of the PV Quality Management System (QMS).
• Ensure compliance with global regulatory requirements (FDA, EMA, MHRA) and ICH-GCP/ICH-E2E guidelines. • Oversee 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). • Develop, review, and approve Standard 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 continuous improvement initiatives to enhance efficiency and compliance with vendors and internally. • Ensure high quality ICSR on time management • Track and interpret changes in regulations within Pharmacovigilance landscape • Works with responsible person/team to author a required regulatory response. • Monitor key quality and compliance metrics, identify risks, and recommend mitigation strategies. • Conduct internal and external vendor quality reviews and gap assessments r/t safety.
• Support global safety reporting quality oversight. • Provide guidance and training to PV staff on quality standards and compliance expectations. • Serve as a subject matter expert for inspections, regulatory audits, and PV compliance matters. • Cross functional collaboration with Call center, supply chain, Manufacturing (QA) and US QA teams to oversee any quality issues that may arise that involve PSRM. • Collaborate with cross-functional teams (Clinical, Regulatory, Medical Affairs, and Operations) to maintain high-quality safety processes.
Skills • Bachelor’s degree in Life Sciences, Pharmacy, or related field; advanced degree preferred. • Minimum 8–10 years of experience in pharmacovigilance, with at least 3–5 years in PV quality 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 develop and implement quality 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 vision coverage • Generous paid 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 Company Overview • PharmaEssentia 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.
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