Drug Safety, Senior Manager
As Drug Safety, Senior Manager for the Pharmacovigilance team, you’ll to ensure study support across programs. You will be able to contribute across a variety of programs and have broad involvement in work central to Adverum’s strategic goals. You will apply your existing technical skills, learn new skills, and play a key role in Pharmacovigilance and help grow the company and guide its direction!
What you'll do:
- Provide oversight for receipt and processing of SAE Reports, including assessment and QC of coding, as well as generation of queries and edits to narratives.
- Assist with the generation of new SOPs/Work-Instructions and updates for existing SOPs.
- Assist with the generation of the DSUR to include QC of applicable Data Tables and review of literature searches.
- Develop PV Training materials to include PV staff, other internal Adverum staff, and Investigator Meetings.
- ·Must be an RN with a minimum of 10 years of relevant Pharmacovigilance experience
- Must have a working knowledge of current U.S. and International regulatory requirements for safety reporting
- Must have completed appropriate MedDRA training
- Excellent oral, written, and interpersonal communication skills
- Strong organizational skills with a high degree of self-motivation
- Experience as a Pharmacovigilance Trainer would be a plus
The salary range for this position is $177K USD to $197K USD annually, with the opportunity to earn an annual bonus. This salary range is an estimate, and the actual salary may vary based on a candidate’s qualifications, including education, length of experience, location, and market data. Employees in this position are eligible to participate in the applicable Company equity incentive award plan. The amount of incentive varies and is subject to the terms and conditions of the plan. Employees in this position are eligible to participate in the Company’s standard employee benefit programs, which currently include the following: medical, dental, vision, 401k, STD/LTD, life and accident insurance, and either paid time off or flexible paid time off.
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.
At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation