Pharmacovigilance Quality & Compliance Manager

Your Role:

We are seeking a highly motivated and experienced Pharmacovigilance Quality & Compliance Manager to perform and oversee compliance activities within Global Patient Safety (GPS). You will play a key role in ensuring adherence to pharmacovigilance (PV) regulations, company standards, and global guidelines. This position involves supporting and participating in audits and inspections, ensuring regulatory compliance, supporting process improvement, and providing training across the subsidiary organization.

Regulatory & Safety Reporting:

• Ensure PV system is set up for accurate reporting of adverse events and process safety data in compliance with US regulatory requirements
• Maintain compliance of PV systems by supporting development, participating in user acceptance testing, and providing PV system feedback to improve system performance
• Track and analyze compliance and performance metrics (KPIs) to ensure effective processes

Quality Management & Compliance:

• Ensure PV processes and systems comply with regulatory guidelines, company policies, and global standards
• Oversee development, maintenance, and continuous improvement of local PV processes in alignment with global GPS
• Collaborate with cross-functional teams to address compliance issues and improve processes
• Monitor and manage changes in regulations and implement corrective actions to address compliance gaps
• Manage quality issues, including CAPA (Corrective and Preventive Action) implementation and effectiveness reviews
• Provide oversight and document local compliance with PV requirements for audits and regulatory inspections, ensuring inspection readiness

Training & Development:

• Develop and deliver PV training programs for internal staff and external vendors
• Update training content based on new regulatory requirements and best practices
• Monitor training effectiveness and make improvements as needed

 Inspection Readiness:

• Participate in internal and external audits, ensuring accuracy and audit readiness of all documentation
• Provide ongoing support during inspections, ensuring GPS teams and subject matter experts are prepared

Location: onsite-Hybrid 3 days per week in Boston, MA Seaport office

Travel: up 5%

Who You Are:

Minimum Requirements:

• Bachelor’s degree in Sciences, Pharmacy, or a similar science field
• 4+ years of experience in pharmacovigilance and experience with PV systems (e.g., Argus, ArisG) and regulatory reporting tools (e.g. MedDRA, WHODrug, etc.)
• 4 years of strong knowledge of US and global pharmacovigilance regulations, ICH, GCP, and other applicable regulatory guidance documents and standards
• 2 years of proven experience in quality assurance, CAPA management, and compliance monitoring

Preferred Qualifications:

• Advanced degree (Master’s or PhD) in a similar field
• Experience in PV audit and inspection preparation
• Strong analytical, problem-solving, and organizational skills
• Ability to work independently and manage multiple priorities
• Proficiency in MS Office 365 (Excel, Word, PowerPoint, SharePoint, Teams, etc.)
• Excellent communication skills, both written and verbal, with the ability to engage across all levels of the organization.
• Attention to detail and ability to adapt to fast-paced environments