Manager, Pharmacovigilance QA

KPS Life; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

A leading company in the pharmaceutical sector is looking for a Manager of Pharmacovigilance QA. This role involves managing quality and regulatory compliance, conducting audits, and ensuring adherence to Good Pharmacovigilance Practices. The ideal candidate will have a strong background in pharmacovigilance, auditing, and regulatory compliance, with the ability to work collaboratively across departments. This position is remote within the USA, with minimal travel required.

Qualifications

• Minimum 3 years experience, including 2 years in Pharmacovigilance.
• Certified auditing experience preferred.

Responsibilities

• Conduct external supplier audits for Pharmacovigilance.
• Review and approve PV related Deviations and Quality Events.
• Support Regulatory Authority inspections.

Skills

Pharmacovigilance

Auditing

Regulatory Compliance

Education

BS degree in Chemistry

BS degree in Biology

Advanced degree (MS, PhD, MBA)

Tools

Veeva

Job description

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KPS Life is seeking a PV specialist/manager level role with at least 2 years of experience in PV-Quality related roles. Ideally, the individual would be in the Eastern Time Zone based remotely in the USA.

• Timeline: ASAP through end of Dec (possibly extended)
• Minimal travel, maybe 25% for onsite audits
• Veeva experience required

Reporting to the Sr. Manager Pharmacovigilance QA, the Manager of Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical/Clinical Departments. The incumbent will provide support and promote collaboration internally and externally to ensure all systems, processes, and their outcomes comply with applicable international and national standards, regulations, and guidelines in partnership with relevant functions (i.e., Drug Safety and Pharmacovigilance (DSPV) and Medical Information (MI)).

Responsibilities (Essential Role Responsibilities):

• Conduct and/or assist with Pharmacovigilance external supplier audits (such as PV vendors and Specialty Pharmacies), including planning, execution, and reporting.
• Provide guidance to staff to ensure the proposed corrective actions received from the auditees are appropriate and that Quality Events/CAPAs are monitored to completion.
• Support the evaluation and acceptability of Pharmacovigilance vendors for potential use.
• Review and approve PV related Deviations, Quality Events, CAPA, Effectiveness Checks, and Root Cause Analysis Investigations.
• Assist in the review and provide input into the quality sections of the Pharmacovigilance System Master File.
• Support the creation of systems and processes, SOPs/WIs, and other PV related documents.
• Support Regulatory Authority inspections, including inspection preparation training and support; actively support during the inspection and review responses to observations and questions from regulatory agencies.

Position Requirements (Required and Preferred Skills, Experience, and Education):

• Minimum BS degree in Chemistry, Biology, or related life sciences discipline with at least 3 years of experience, including 2 years in Pharmacovigilance.
• Advanced degree (MS, PhD, MBA) preferred; additional years of experience may be considered in lieu.
• Certified auditing experience preferred.
• Experience with pharmacovigilance in Phases I-IV (particularly Phase III) and post-marketing.
• Basic knowledge of FDA, EU, and ICH regulations, pharmacovigilance processes, and HA inspection procedures.
• Experience developing and reviewing SOPs and PV, clinical, regulatory, and medical processes.
• Ability to conduct external audits on PV vendors, CROs, and monitoring organizations, including report writing and CAPA tracking.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance, Research, and Project Management

Industries

• Research Services, Biotechnology Research, and Pharmaceutical Manufacturing