Senior Manager/Associate Director Pharmacovigilance

I am partnered with an innovative and expanding pharmaceutical organization who is looking to bring on their first Safety hire in the US. They have offices across multiple countries and an extensive portfolio of essential medicines significantly impacting patient's lives. Their commitment to innovation, patient safety, and making a real difference in the lives of patients and caregivers provides a strong sense of purpose and fulfillment to their team members. If you are interested in the opportunity to be part of a mission-driven company that values collaboration, excellence, and continuous improvement, please reach out!

Overview: The Associate Director of Drug Safety in the U.S. manages the safety and risk assessment of pharmaceutical products and medical devices throughout their life cycle. This role ensures adherence to regulatory standards and internal protocols, working collaboratively with cross-functional teams to uphold patient safety and product integrity.

Key Responsibilities:

• Lead drug safety activities for the U.S. market, ensuring compliance with regulatory requirements (e.g., FDA, EMA).
• Develop and maintain strong relationships with headquarters and U.S. local operations.
• Ensure timely collection, processing, and reporting of adverse events.
• Oversee the creation and implementation of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).
• Ensure compliance with applicable drug safety regulations and guidelines.
• Collaborate with clinical development, medical affairs, regulatory affairs, and quality departments.
• Provide training to the Drug Safety team on local regulations and FDA inspections.
• Manage third-party vendors involved in drug safety activities.
• Ensure the accuracy and quality of drug safety data.
• Lead or participate in internal and external drug safety audits and inspections.

Qualifications:

• Advanced degree (PhD, PharmD, MD) in life sciences, pharmacology, or related field, or equivalent experience.
• Minimum of 8-10 years of experience in drug safety or pharmacovigilance.
• In-depth knowledge of regulatory requirements and guidelines (e.g., FDA, ICH).
• Strong understanding of safety assessments and regulatory reporting.
• Excellent communication and presentation skills.
• Strong organizational and project management abilities.
• Experience working with global teams.