EVERSANA | Associate Director
3 days ago
Job Description
ESSENTIAL DUTIES AND RESPONSIBILITIES: Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:
1. Project Delivery & Oversight
o Lead the end-to-end delivery of pharmacovigilance projects, ensuring all milestones are met on time and within scope.
o Oversee the execution of pharmacovigilance processes, including adverse event reporting, signal detection, and safety data management, ensuring high-quality output in line with client requirements.
2. Team Management & Development
o Manage and mentor a team of pharmacovigilance professionals, fostering a collaborative, high-performance culture.
o Provide ongoing training and development opportunities to enhance team expertise in pharmacovigilance regulations, safety reporting, and industry best practices.
o Conduct regular performance reviews, offering feedback, guidance, and support to drive team growth and alignment with organizational objectives.
3. Contractual Compliance
o Ensure all projects are delivered in full compliance with contractual agreements, including timelines, quality standards, and regulatory requirements.
o Oversee the monitoring and reporting of service level agreements (SLAs), taking corrective action as needed to ensure compliance.
4. Client Communication & Relationship Management
o Serve as the primary point of contact for clients, maintaining transparent and proactive communication regarding project progress, safety data, and deliverables.
o Manage client expectations, addressing any concerns promptly and ensuring client satisfaction through consistent, high-quality service delivery.
5. KPI Compliance & Reporting
o Establish and track key performance indicators (KPIs) to assess team performance, project delivery timelines, and client satisfaction.
o Analyze performance data and implement corrective actions when necessary to ensure continued compliance with KPIs and improve operational efficiency.
Qualifications
• PHD OR MASTER’S DEGREE OR MEDICAL DEGREE (MD), DOCTOR OF PHARMACY (PHARMD) in a relevant field such as PHARMACOVIGILANCE, PHARMACY, PHARMACEUTICAL SCIENCES, MEDICINE, LIFE SCIENCES or, or MASTER OF PUBLIC HEALTH (MPH) or a closely related discipline is preferred.
Additional information
• 13+ years of experience in Pharmacovigilance delivery, with regulatory compliance.
• At least 5 years in a leadership/Team handling role, managing or directing a team within Pharmacovigilance, Drug Safety, or a related area.
• Proven experience in managing the entire pharmacovigilance lifecycle, from adverse event reporting to signal detection and risk management.
• Experience with regulatory authorities such as the FDA, EMA, MHRA, and other global bodies for pharmacovigilance-related submissions and inspections.
• Strong experience with pharmacovigilance databases (e.g., Argus, Veeva Vault QMS, or similar) and proficiency in safety data management and analysis.
• Proven experience in leading projects to successful completion with seamless execution, ensuring client satisfaction by effectively managing and meeting client requirements.
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