Associate Director, Pharmacovigilance, US

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 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 assigned products in the U.S., ensuring adherence to regulatory requirements (FDA, EMA, etc.) and company procedures.
• 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 local requirements).
• 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 compliance with regulatory timelines.

 

Cross-Functional Collaboration:

• Collaborate with clinical development, medical affairs, regulatory affairs, 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, 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: