Director, Pharmacovigilance Operations

Description

Summary: This section focuses on the main purpose of the job in one to four sentences.

The Director, Pharmacovigilance Operations is responsible for providing day-to-day oversight of the TerSera Pharmacovigilance (PV) System and ensuring that delegated PV activities are performed in compliance with applicable regulatory requirements, company procedures, and partner obligations.

The position serves as the operational governance lead for the PV system and is responsible for vendor oversight, inspection readiness, compliance monitoring, training governance, PV agreement implementation, quality oversight activities, and maintenance of key pharmacovigilance governance processes. The Director partners closely with the Vice President, Pharmacovigilance, and collaborates across Regulatory Affairs, Quality Assurance, Medical Affairs, Commercial, Clinical, and external service providers. 

The level of the position will be commensurate with experience. This position reports to the VP of Pharmacovigilance and can be remote, hybrid or located at our headquarters in Deerfield, IL

Essential Duties and Responsibilities: This section contains a list of the major responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.

PV Operations Oversight

• Provide oversight of delegated pharmacovigilance activities, including case processing, reporting, literature surveillance, reconciliations, and other outsourced PV services.
• Monitor operational performance and compliance metrics.
• Identify, investigate, and escalate actual or potential PV compliance issues.
• Coordinate review and follow-up of operational trends and performance indicators.
• Support implementation of new products, partners, and business initiatives affecting PV activities.

Vendor and Partner Governance

• Lead oversight of PV vendors, CROs, license partners, patient-support service providers, and other external parties.
• Maintain oversight of vendor performance and contractual/PVA obligations.
• Coordinate periodic governance reviews and performance discussions.
• Escalate significant compliance, quality, or operational concerns.
• Support due diligence, onboarding, transition, and oversight activities for new vendors and partners.

Inspection Readiness and Compliance

• Coordinate ongoing inspection-readiness activities.
• Maintain readiness for FDA, Health Canada, partner, and internal audits.
• Support regulatory inspections and vendor audits.
• Coordinate inspection responses, commitments, and follow-up activities.
• Maintain inspection-support materials and evidence retrieval processes.

PV Quality System Oversight

• Support implementation and maintenance of the pharmacovigilance quality framework.
• Monitor deviations, quality events, CAPAs, audits, inspections, and corrective actions.
• Support periodic review of PV system health and compliance trends.
• Participate in risk assessments and continuous-improvement initiatives.

Training and Controlled Documentation

• Oversee PV training governance processes.
• Ensure appropriate training requirements are established and maintained for personnel and applicable external parties.
• Support maintenance of PV procedures, work instructions, governance records, and related documentation.
• Ensure inspection-ready documentation and evidence repositories are maintained.

PV Agreements and Governance Processes

• Support development, implementation, and maintenance of Pharmacovigilance Agreements (PVAs) and related partner governance documents.
• Monitor obligations arising from PVAs and related contracts.
• Coordinate periodic reviews and updates of partner oversight documentation.

Leadership and Cross-Functional Collaboration

• Serve as primary operational liaison between Pharmacovigilance and internal stakeholders.
• Provide leadership for PV governance meetings and oversight reviews.
• Present compliance trends, risks, and recommendations to PV leadership.
• Support strategic initiatives and organizational change activities impacting the PV system.

Non-Essential Functions: Standard non-essential functions for all TerSera Therapeutics employees.

• Strives to maintain a safe working environment through the prevention of accidents, the preservation of equipment, and the achievement of safe working practices
• Maintains a positive and professional demeanor toward all customers and coworkers 
• Adheres to all policies and procedures of TerSera Therapeutics
• Performs other duties as assigned.

Requirements

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Demonstrated experience with vendor oversight; PV Agreements; compliance monitoring; inspection readiness; regulatory reporting requirements; quality systems and CAPA management
• Knowledge of FDA, Health Canada, ICH, and global pharmacovigilance requirements.
• Experience supporting FDA inspections and Health Canada inspections. 
• Experience within specialty pharmaceutical, biotechnology, or highly outsourced pharmacovigilance environments. 
• Experience managing license partner safety obligations and safety data exchange processes.
• Critical Competencies
• Technical: PV regulations and compliance; vendor governance; inspection readiness, quality systems; risk management; PV agreements; compliance metrics and oversight

Leadership: strategic thinking; influence without authority; strong organizational skills; effective communication; cross-functional collaboration; problem solving; decision making

Education and/or Experience: Education and experience that is necessary to perform the job satisfactorily.

• Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in pharmacovigilance 
• A minimum of 10 years of experience in pharmaceutical/ biotechnology industry with at least 7 years of experience in pharmacovigilance operations