Associate Director, Pharmacovigilance, US

Job Requisition ID: 32441 Department: SAFETY Category: Medical - Safety Location: Philadelphia Date: 12 Apr 2025 Come and Save Lives with Us! SERB Pharmaceuticals is a growing international specialty pharmaceutical group that is a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases. We have over 470 employees in 16 countries and a group revenue in excess of €350m. Our portfolio 80+ rescue medicines make a real difference in the lives of patients and their caregivers and that gives every one of our employees a sense of purpose. Our Purpose is supported by our 4 key values: We make patients our priority We act with integrity and accountability We work together as one team We look for better ways forward Broad Overview 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. As Associate Director, Pharmacovigilance, US, your responsibilities will include: Pharmacovigilance Oversight: 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. Safety Risk Management: 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. Regulatory Compliance: 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. Cross-Functional Collaboration: 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. Trainings and organization 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. Vendor Management: 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. Data Management and Reporting: 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. Internal and External Audits: 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. The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements. To be successful in this role, you should demonstrate: 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. Company Benefits: Vacation, Sick and Personal Time Medical, Dental, Vision and other Voluntary benefits Paid Parental Leave Tuition Assistance Discretionary Bonus Plan Competitive 401(k) EEO Disclaimer: SERB is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any protected characteristic protected by federal, state, or local laws. If you require a reasonable accommodation in completing this application, interviewing, completing any pre-employment requirements, or otherwise participating in the employee selection process, please direct your inquiries to the HR Department. Serb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.

Salary : $119,000 - $159,000