Senior Director, Safety and Pharmacovigilance

About the role

As a Senior Director of Safety and Pharmacovigilance at Artivabio, you will play a pivotal role in ensuring the safety and efficacy of our innovative therapies. You will lead a dedicated team responsible for monitoring and evaluating the safety profiles of our products throughout their lifecycle. This position requires a strategic thinker with extensive experience in pharmacovigilance and a deep understanding of regulatory requirements. Your leadership will be essential in guiding the development of safety strategies that align with our mission to provide groundbreaking treatments.

Key facts

What you'll do

• Oversee the pharmacovigilance operations, ensuring compliance with global regulatory requirements and industry standards.
• Develop and implement safety monitoring strategies for clinical trials and post-marketing surveillance, ensuring timely identification and management of safety signals.
• Lead a team of safety professionals, providing mentorship and fostering a culture of continuous improvement and excellence in safety practices.
• Collaborate closely with cross-functional teams, including clinical development, regulatory affairs, and quality assurance, to integrate safety considerations into all stages of product development.
• Prepare and review safety-related documents, including clinical study reports, risk management plans, and periodic safety update reports (PSURs).
• Serve as the primary point of contact for regulatory agencies regarding safety matters, ensuring effective communication and compliance with reporting obligations.
• Conduct safety assessments and risk evaluations, utilizing data analytics to inform decision-making and enhance patient safety.
• Stay abreast of industry trends, regulatory changes, and advancements in pharmacovigilance methodologies to ensure Artivabio remains at the forefront of safety science.
• Lead the development and execution of training programs to enhance the pharmacovigilance knowledge and skills of team members and stakeholders.
• Participate in strategic planning and contribute to the overall safety strategy of the organization, aligning with Artivabio's goals and objectives.
• Foster relationships with external stakeholders, including healthcare professionals, patients, and advocacy groups, to gather insights and enhance the safety profile of our products.
• Manage budgets and resources effectively to ensure the pharmacovigilance team operates efficiently and meets organizational goals.

Requirements

• A Master's degree or higher in a relevant scientific discipline, such as pharmacology, medicine, or life sciences.
• A minimum of 10 years of experience in pharmacovigilance or drug safety, with at least 5 years in a leadership role.
• In-depth knowledge of global pharmacovigilance regulations, guidelines, and best practices.
• Proven track record of successfully managing safety operations in a biopharmaceutical environment.
• Strong analytical skills and the ability to interpret complex data sets to inform safety decisions.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across diverse teams.
• Experience in developing and implementing safety strategies for both clinical and post-marketing phases.
• Familiarity with electronic pharmacovigilance systems and data management tools.
• Strong project management skills, with the ability to prioritize and manage multiple initiatives simultaneously.
• A proactive approach to problem-solving and a commitment to maintaining high standards of safety.

Nice to have

• Experience in gene therapy or advanced therapeutic medicinal products (ATMPs) is a plus.
• Previous experience working with regulatory agencies such as the FDA or EMA.
• Familiarity with risk management frameworks and methodologies.
• Experience in conducting safety audits or inspections.
• Proficiency in statistical analysis software or programming languages relevant to data analysis.

Skills & tools

• Strong leadership and team management capabilities.
• Proficient in pharmacovigilance databases and reporting tools.
• Excellent organizational and time management skills.
• Ability to synthesize complex information and present it clearly to various stakeholders.
• Strong understanding of clinical trial processes and regulatory submissions.

Practical notes

• The specific location for this role is currently unknown.
• Salary information has not been disclosed.
• Visa sponsorship details are not provided, and candidates should verify their eligibility to work in the relevant jurisdiction.

If you are passionate about patient safety and have the expertise to lead a dynamic pharmacovigilance team, we invite you to apply for this exciting opportunity at Artivabio. Join us in our mission to develop innovative therapies that can transform lives.