Director/Senior Director, Pharmacovigilance Operations

Director / Senior Director, Pharmacovigilance Operations

About Edgewise Therapeutics :

At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders.

We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!

About the Position :

As Director / Senior Director, Pharmacovigilance Operations, you will provide strategic and operational PV oversight and support for Edgewise's development products. In this role you will be tasked with standardizing the approach to global clinical trial and future post marketing PV operations across our therapeutic areas so that we can consistently produce quality and timely deliverables. This position will also serve as the initial point of contact and recipient for all incoming SAEs. Responsibilities will include collection, initial assessment, electronic filing, and data entry of serious adverse event (SAE) data, both clinical & post-marketed, into a global safety database. Initial safety narrative writing may also be required.

Essential Job Duties and Functions :

• Oversee medical surveillance and risk management for investigational products
• Report Management : Lead the creation and coordination of pharmacovigilance reports (DSUR, PBRER, etc.), ensuring stakeholder input and regulatory timelines are met
• Safety Surveillance : Perform safety surveillance, signal detection, and benefit-risk assessments
• Collaboration : Work closely with stakeholders to ensure comprehensive safety reviews, and lead Safety Review Team meetings
• Regulatory Compliance : Ensure compliance with regulatory and Risk Management Plan (RMP) commitments, and support clinical programs and registration activities
• Training and Guidance : Provide training to internal teams and oversight of pharmacovigilance vendors
• Audit Support : Conduct PV audits and regulatory inspections
• Oversight of the PV operational and case management activities for safety reporting including the collection, processing, and reporting / submission of safety information.
• Assume point of contact role for the Data Monitoring Committee activities across the program through timely communication, active contribution on compiling and delivering data to the committee.
• Collaborate with study team members to develop documents related to safety case processing and reporting (e.g., Safety Management Plan, reconciliation plan, SAE report form and completion guidelines, and all safety vendor documents).
• Provide Safety Operational support to clinical trial study teams as needed.
• Develop and maintain Safety Data Exchange Agreements (SDEAs) and PV agreements with partners, vendors, and other third parties.
• Collaborate with internal teams to prepare for Regulatory Authority inspections and in relevant internal / external audits.
• Transition processes and create new infrastructure into a post marketing landscape, when applicable.
• Work with senior leaders to establish and / or optimize a strategy for organizational build, process improvement initiatives and operational efficiency as our product portfolio grows.
• Provide advice and support to other internal departments with respect to drug safety standards and requirements.
• Serve as a subject matter expert for internal audits and global regulatory inspections.
• Monitor the Drug Safety Inbox for all incoming SAE reports.
• Assess SAE reports for completeness, consistency, serious criteria and expectedness.
• Other PV activities appropriate to experience and expertise.

Required Education, Experience and Skills :

Salary range : $165,000-$290,000, title and salary commensurate with experience

Our Benefits : We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.

There is no deadline because the employer accepts applications on an ongoing basis.

Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.

Salary : $165,000 - $290,000