Pharmacovigilance Operations Manager

📋 Description

• Serve as the local safety office for the US/EU and act as the FDA/EMA contact point for safety reporting.

• Assist in the submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors.

• Facilitate interactions with business partners (license partners) and vendors concerning all case intake and processing activities.

• Oversee vendor activities related to case intake processing and ensure the quality of cases, including trend analysis and reporting on quality measures.

• Ensure vendor adherence to approved processes and training requirements.

• Provide support for audits and external inspections.

• Manage multiple relationships with business partners for case management.

• Monitor compliance with regulatory submissions and contractual agreements for data exchange.

• Carry out tasks assigned by the QPPV as outlined in the PV System Master File and maintain readiness for inspections.

• Act as a representative and point of contact for Health Authority Inspections and Internal Process Audits within the scope of the role and responsibilities.

⛳️ Requirements

• Doctorate Degree.

• Master’s degree with 2 years of directly related experience, or Bachelor’s degree with 4 years of directly related experience, or Associate’s degree with 8 years of directly related experience, or High school diploma/GED with 10 years of directly related experience.

• Prior experience in directly managing teams, projects, programs, or directing resource allocation.

• Knowledge of global regulatory requirements for pharmacovigilance.

• Experience in project leadership.

• Proficiency in safety systems.

• Experience supporting inspections or internal audits.

• Proficient in Microsoft Suite: Word, Excel, PowerPoint, Project, and Outlook.

🏝️ Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where applicable.