Senior Manager, Global Pharmacovigilance Quality Assurance

Beacon Hill; United States; Remote; USD 100,000 - 304,000; Full time

Job summary

A leading company in the biopharmaceutical sector is seeking a Senior Manager, Global Pharmacovigilance Quality Assurance. The role involves ensuring quality oversight, supporting GVP compliance, and leading audit programs within the pharmacovigilance framework. This remote position requires a life sciences background and extensive experience in quality assurance and regulatory standards.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• 5+ years experience in quality issues and risk management.
• Expertise in GVP regulations and FDA requirements.
• Experience in pharmaceutical industry compliance functions.

Responsibilities

• Provide Quality oversight of global post-marketing pharmacovigilance.
• Support GVP audit program execution and regulatory activities.
• Develop GVP QA training and support inspection readiness.

Skills

Quality oversight

Analytical skills

Communication skills

Interpersonal skills

Regulatory knowledge

Education

University degree in life sciences

Tools

Auditing tools

Job description

Senior Manager, Global Pharmacovigilance Quality Assurance

Direct message the job poster from Beacon Hill

Senior Clinical Research Recruiter / Talent Acquisition - Beacon Hill Pharma

A highly reputable biopharmaceutical company is looking for a qualified Senior Manager, Global Pharmacovigilance Quality Assurance open to working remotely in the United States based in eastern time zone.

Responsibilities:

• Member of the GVP QA team providing Quality oversight of 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 the companies Inspection activities.
• This position reports to the Director, Global PV Quality Assurance and frequently interacts with cross-functional teams.

Summary of Key Responsibilities:

• Senior Manager, PV QA supports all the GVP QA’s responsibilities as listed below. Different members of the team will have particular focus areas. Senior Manager will lead specific activities:
• Serve as a strong partner with Expertise Areas (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. Applies risk-based thinking in determining required actions.
• Effectively communicate and escalate 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 develop PV audit schedule.
• 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
• 5+ years of experience supporting quality issues and risks, background in audits and PCMF support, Experienced with medical affairs and regulatory requirements.
• Extensive experience in the pharmaceutical industry in a quality or compliance function.
• Audit skills and experience of 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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Project Management

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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