EVERSANA - Director - Pharmacovigilance Operations

Experience: 13+ years in pharmacovigilance delivery, with at least 5 years in a leadership role.

Qualification: Advanced degree (PhD, MD, PharmD, MPH, or Master's in a related field) preferred.

About the Job:

- We are seeking an experienced and dynamic Director of Pharmacovigilance Operations to oversee the end-to-end delivery of pharmacovigilance projects, ensuring compliance with regulatory standards and excellence in client service.

- The ideal candidate will possess a strong background in pharmacovigilance, team management, and client relationship management.

Roles and Responsibilities:

Project Delivery and Oversight:

- Lead and manage the delivery of pharmacovigilance projects, ensuring timely achievement of milestones within scope.

- Oversee pharmacovigilance processes, including adverse event reporting, signal detection, and safety data management, ensuring quality and regulatory compliance.

Team Management and Development:

- Manage and mentor a team of pharmacovigilance professionals to foster a collaborative and high-performance culture.

- Provide ongoing training to enhance expertise in pharmacovigilance regulations and industry best practices.

- Conduct regular performance reviews and provide guidance to align with organizational objectives.

Contractual Compliance:

- Ensure projects meet contractual obligations, including timelines, quality standards, and regulatory requirements.

- Monitor and report SLAs, implementing corrective actions to maintain compliance.

- Client Communication and Relationship Management

- Act as the primary point of contact for clients, ensuring transparent and proactive communication.

- Address client concerns promptly and ensure satisfaction through consistent, high-quality service delivery.

KPI Compliance and Reporting:

- Establish and track key performance indicators (KPIs) to evaluate team performance and operational efficiency.

- Analyze performance data and implement improvements to ensure KPI compliance.

Skills and Qualifications:

- Advanced degree in pharmacovigilance, pharmacy, pharmaceutical sciences, medicine, life sciences, public health, or a related field.

- 13+ years of experience in pharmacovigilance delivery with regulatory compliance expertise.

- At least 5 years of leadership experience managing teams in pharmacovigilance or drug safety.

- Proven experience managing the pharmacovigilance lifecycle, including regulatory submissions and inspections with bodies like FDA, EMA, and MHRA.

- Expertise with pharmacovigilance databases such as Argus or Veeva Vault QMS.

- Strong knowledge of safety data management and regulatory compliance requirements.

- Demonstrated ability to lead projects successfully while meeting client requirements and expectations