Lead Pharmacovigilance Scientist

About the Role

Our client is seeking an experienced and dedicated Lead Pharmacovigilance Scientist to join their global safety team. This is a fully remote position that will allow you to take on significant responsibilities in ensuring the safety of our client's pharmaceutical products worldwide. You will be instrumental in managing safety surveillance activities, conducting signal detection, and contributing to risk management strategies. The ideal candidate is a meticulous professional with a deep understanding of regulatory requirements and a passion for patient safety, working effectively within a distributed international team.

Key Responsibilities

• Oversee and manage all aspects of pharmacovigilance activities, including adverse event reporting and case processing.
• Conduct comprehensive signal detection and risk assessment for assigned products, utilizing various data sources.
• Develop and implement risk management plans (RMPs) and contribute to periodic safety update reports (PSURs).
• Liaise with regulatory authorities, internal departments, and external stakeholders on safety-related matters.
• Provide expert guidance and training to team members and other departments on pharmacovigilance principles and procedures.
• Ensure compliance with global regulatory guidelines and company policies.

Requirements

• Advanced degree (e.g., MD, PharmD, MSc, PhD) in a relevant scientific or medical field.
• Minimum of 7 years of progressive experience in pharmacovigilance or drug safety within the pharmaceutical industry.
• Extensive knowledge of global regulatory requirements (e.g., FDA, EMA) for pharmacovigilance.
• Proven experience in signal detection, risk assessment, and benefit-risk evaluation.
• Strong leadership, communication, and interpersonal skills, with the ability to work effectively in a remote, global setting.
• Proficiency in safety databases and reporting systems.

Benefits

• Highly competitive annual salary with potential for bonuses.
• Comprehensive healthcare coverage including medical, dental, and vision.
• Flexible remote work arrangement and support.
• Generous paid time off and holidays.
• Opportunities for career advancement and professional development in a growing field.