Director of Drug Safety

About the Company

Join an accomplished biotechnology (BioTech) company that values innovation and patient safety.

Industry
Biotechnology

Type
Privately Held

About the Role

We are seeking a passionate and experienced Director of Drug Safety to lead our pharmacovigilance function and prioritize the safety and well-being of our patients. In this pivotal role, you will oversee all aspects of drug safety and pharmacovigilance, ensuring rigorous safety data review, proactive signal detection, effective risk communication, and the implementation of risk mitigation strategies. You will provide vital medical and drug safety expertise to support strategic decision-making and play an integral part in our clinical leadership team. Your responsibility will also encompass the management of a growing safety operations team dedicated to monitoring and assessing safety activities.

Your role will include providing essential input for regulatory agency inquiries and managing the safety data management and reporting system, ensuring compliance with global regulatory standards. We are looking for candidates with an MD and at least 7 years of relevant experience in drug safety, preferably within pharma or biotech environments. Familiarity with hematology/oncology medical concepts is highly desirable.

The ideal candidate will demonstrate effective leadership qualities, possess a solid background in clinical trials, and exhibit a strong understanding of safety reporting and risk management protocols. Excellent communication skills, the ability to multitask in a dynamic environment, and a proactive mindset are crucial in ensuring the effectiveness of our drug safety systems. Responsibilities will also include leading the development of safety-related documentation, maintaining audit readiness, and building robust relationships with internal teams and external partners.

Hiring Manager Title
Chief Medical Officer

Functions
• Medical Care/Hospital Administration