Consultant Director, Medical Safety/Pharmacovigilance
Our client is a late-stage biopharmaceutical company focused on discovering, developing and commercializing next-in-class muscle activators and best-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. We take a purpose-driven approach by leveraging our unique muscle biology expertise to engineer compounds with specific characteristics aimed at treating diseases that impact muscle function, like heart failure, hypertrophic cardiomyopathy, ALS and SMA.
We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the our client’s team, contributing to our shared goal of improving lives. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop potential medicines to improve the healthspan of people with cardiovascular and neuromuscular diseases of impaired muscle function.
The Consulting Director, Medical Safety/Pharmacovigilance is a role we will look to bring full-time late this year. As our Consulting Director, you will be responsible for leading global pharmacovigilance activities for the company, including the detection and analysis of safety issues for investigational drug products in compliance with global pharmacovigilance and regulatory requirements. The position provides medical and strategic input for adverse event monitoring, coding, and signal detection to ensure that global PV regulatory requirements for case reporting and management are met. The position will report to the Head of Drug Safety and Pharmacovigilance and will work collaboratively within the Drug Safety and Pharmacovigilance department, across departments, and with partner companies to achieve PV and company goals.
Responsibilities
· Under the direction of the Head of Drug Safety and Pharmacovigilance, perform signal detection activities to ensure signal identification and evaluation, including individual and aggregate data analyses, interpretation of safety signals and trends, and documentation and communication of safety assessments for all investigational products
· Participate in safety surveillance strategy and activities for all our client’s investigational products, including development and implementation of relevant policies and procedures
· Conduct medical review of individual case safety reports
· Contributes to the creation of analysis of similar events
· Collaborate with partners on safety monitoring and signal detection and risk management activities
· Participate in establishing and maintaining Safety Data Exchange Agreements
Collaborate, contribute to and review relevant sections of clinical and regulatory