SENIOR MANAGER, GLOBAL PHARMACOVIGILANCE (PV) QUALITY ASSURANCE

Planet Pharma; Cambridge (MA); Presencial; USD 117.000 - 131.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Equal Opportunity Employer

Descripción de la vacante

Planet Pharma seeks a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to oversee the global post-marketing PV system, ensuring GVP compliance, PMS execution, audits, and inspection readiness. The role reports to the Director, Global PV Quality Assurance and collaborates with cross-functional teams in EA.

This on-site, contract position is based in Cambridge, MA with an hourly pay range of $85–$95 based on experience.

Formación

• University degree in life sciences or equivalent.
• Experience in pharmaceutical quality/compliance.
• Experience with GVP audits and regulatory inspections.
• Understanding of FDA PV requirements and ICH.
• Strong communication and cross-functional collaboration.

Responsabilidades

• Lead PV QA audits and inspections readiness for the PV system.
• Oversight of global PV quality processes, CAPA management, and risk-based quality assurance.
• Collaborate with cross-functional teams (EA) to ensure GVP compliance and training.
• Develop and maintain PV QA metrics, dashboards, and GVP training plans.
• Support vendor qualification, audits, and PV system master file data management.

Conocimientos

Quality Assurance

GVP Audits

Regulatory Compliance

Audit Experience

Communication Skills

Problem Solving

Educación

University degree in life sciences

Descripción del empleo

Senior Manager, Global Pharmacovigilance (PV) Quality Assurance

Location: Cambridge, Massachusetts

Category: Pharmacovigilance

Salary: Apply for details

Country: United States

Employment: Contract

Worksite: On-Site

Job Description

This role is a member of the GVP QA team providing Quality oversight of the global post-marketing pharmacovigilance system, including clinical safety, full application of EMA Good Pharmacovigilance Practices (GVP) Modules, and implementation of other worldwide PV regulations. This includes support for the development and execution of the GVP audit program as well as contributing to Inspection activities.

This position reports to the Director, Global PV Quality Assurance and frequently interacts with cross-functional teams (which are generally termed Expertise Areas, EA).

Summary Of Key Responsibilities

Manager Will Lead Specific Activities

• Serve as a strong partner with EAs in the enhancement of the global pharmacovigilance system, including ensuring compliance with GVP regulations. This includes review of procedural documents.
• Partner and support EAs in ensuring conduct of non-interventional, observational, and post-marketing surveillance (PMS) meet regulatory requirements and expectations considering Good Pharmacoepidemiology Practice (GPP) and Good Post-marketing Study Practice (GPSP).
• Support cross-GxP QA activities requiring PV and PMS expertise.
• Execute on global core auditing processes for licensing partners, external vendors, internal audits, affiliates, and other applicable service providers in a post-marketing environment.
• Determine, evaluate, and investigate Quality Events. Determine adequacy of root cause analyses and CAPAs. Apply risk-based thinking in determining required actions.
• Effectively communicate and elevate critical matters to management.
• Support the Global Strategic Audit Program — contribute to risk-based audit strategy and maintain and enhance PV audit universe, risk tools, and support lifecycle management of PV audit schedule. Support audit conduct which may include preparation and planning of audits, conduct of audits remotely and in person, reporting audits and close out of audit findings, including CAPA management.
• Provide QA Audit, CAPA, and Supplier data for the PV System Master File (PSMF). Develop and maintain efficient processes to ensure comprehensive and accurate data.
• Develop and maintain processes and tools to support quality audit execution and outcomes.
• Support PV/post-marketing surveillance inspection readiness and inspection management activities.
• Provide Quality oversight of PV, PMS, and PV-related vendors. This includes vendor notification, qualification assessments, Quality Agreements, KQIs, and audits.
• Develop and report GVP QA metrics and dashboards to support quality oversight.
• Develop and maintain GVP QA Training Plan; conduct PV and PMS training sessions for QA and EAs.
• Lead or contribute to Quality or PV and PMS initiatives. Identify and propose process improvement opportunities and solutions.
• Other assignments as directed.

Requirements And Skills

• Educated to university degree (preferably life sciences) or equivalent qualification or experience.
• Extensive experience in the pharmaceutical industry in a quality or compliance function.
• Audit skills and experience conducting GVP audits is preferred.
• Understanding of and working experience with international GVP regulations, FDA PV requirements, Health Authority guidances, and ICH.
• Experience supporting Health Agency inspections.
• Self-motivated with the ability to demonstrate initiative and internal drive for continuous improvement.
• Strong interpersonal, verbal, and written communication skills. Builds positive and productive working relationships.
• Diplomatic in addressing sensitive issues confidentially and professionally. Works professionally with confidential information.
• Ability to analyze complex situations/issues. Demonstrates strategic thinking.

Pay ranges between 85-95/hr based on experience

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us(opens in new tab) directly so that we can explore the appropriate arrangements.