Associate Director

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.