Associate Director, Pharmacovigilance, US

SERB • Philadelphia, PA

6d • Hybrid

About The Position

The Associate Director of Pharmacovigilance (PV) in the U.S. is responsible for overseeing the safety and risk management of pharmaceutical products and medical device throughout their lifecycle. This role ensures compliance with regulatory requirements and internal processes related to drug safety, and collaborates with cross-functional teams to support patient safety and maintain product integrity. The individual in this role will provide leadership in monitoring, assessing, and reporting adverse events, while ensuring that pharmacovigilance operations align with industry best practices, regulations, and corporate objectives.

Requirements

• Advanced degree (PhD, PharmD, MD) in life sciences, pharmacology, or related field, or equivalent experience.
• Minimum of 8-10 years of experience in pharmacovigilance or drug safety.
• In-depth knowledge of regulatory requirements and guidelines (e.g., FDA, ICH).
• Experience with adverse event reporting systems in the USA, PADERs & Annual reports drafting, and signal detection methodologies.
• Strong understanding of safety assessments, and regulatory reporting.
• Proven ability to work cross-functionally and participate to audits and inspections (including the preparation).
• Excellent communication and presentation skills.
• Strong organizational and project management abilities.
• Ability to analyze data and make informed feedback.
• Experience working with global teams.

Responsibilities

• Lead the pharmacovigilance activities for the US territory and for assigned products in the U.S., ensuring adherence to regulatory requirements (FDA, EMA, etc.) and company procedures.
• Participate to build a pharmacovigilance function and build strong relationships with headquarter and US local operations (notably Regulatory and Quality)
• Ensure the timely collection, processing, and reporting of adverse events, including serious adverse events (SAEs) and non-serious adverse events (NSAEs).
• Review and assess adverse event reports and other safety data to identify trends or signals, and escalate critical issues as needed.
• Oversee the development and execution of Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and other safety monitoring strategies.
• Collaborate with internal and external stakeholders to assess and manage safety risks associated with company products.
• Ensure compliance with applicable pharmacovigilance regulations and medical device regulations, guidelines, and standards (including ICH E2E, FDA, EMA, and all applicable law and regulation in US).
• Ensure a regular watch on local applicable law and regulations and participate actively to the continuous improvement of the pharmacovigilance system.
• Maintain up-to-date knowledge of regulatory developments and changes in safety reporting requirements.
• Prepare and submit periodic safety reports (e.g., PADERs, Annual Reports) in coordination with regulatory department and in compliance with regulatory timelines.
• Collaborate with clinical development, medical affairs, regulatory affairs, quality and other departments to assess product safety and support decision-making.
• Provide safety-related input into clinical trials, marketing authorization applications (MAAs), and other product development activities.
• Provide training to the Vigilance team, for the local applicable law and regulation and from previous experiences for FDA inspections regarding pharmacovigilance and medical device, where applicable.
• Oversee and manage third-party vendors or contract research organizations (CROs) involved in pharmacovigilance activities.
• Ensure that external partners comply with relevant safety standards, contractual obligations, and regulatory requirements.
• Ensure the accuracy and quality of pharmacovigilance data, including the implementation of data quality improvement initiatives.
• Oversee the preparation of safety data reports and contribute to the overall safety profile of products.
• Participate to Due Diligences, specifically for US products.
• Lead or participate in internal and external pharmacovigilance audits and inspections, specifically from FDA.
• Implement corrective actions to address findings and ensure continuous improvement in PV processes.

Benefits

• Hybrid Working
• Vacation, Personal and Sick time
• 15 Paid Company Holidays
• Medical, Dental, Vision and other Voluntary benefits
• Paid Parental Leave
• Tuition Assistance
• Discretionary Bonus Plan
• Competitive 401(k), $1 for $1 up to 6% of pay. The safe harbour match is vested immediately. In addition, SERB also offers a discretionary match of up to 4% of pay which vests 20% a year for 5 years.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree