Manager, Drug Safety Operations
Denali Therapeutics
Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.
The Opportunity
Denali is seeking a Manager of Drug Safety Operations, reporting to the Director of Drug Safety Operations, to join our team. You will be responsible for working with Drug Safety colleagues, cross-functional study teams, and external vendors to manage and support drug safety and pharmacovigilance operational activities within the Denali clinical development framework.
This individual must be able to work in a spirit of collaboration and service, while also operating with a high level of independent judgment. Denali is seeking candidates with a can-do attitude who work with the highest integrity, fostering an environment of compliance and continuous improvement.
Responsibilities
- Serve as the primary Drug Safety lead on study teams for assigned studies, and liaise with other Denali functions (including Clinical Operations, Clinical Science, Quality Assurance, Regulatory, and Clinical Data Management) as well as external vendors and services providers contracted by Denali in performing drug safety study start-up, maintenance, and close-out activities
- Participate in authoring, reviewing, and updating of study documents such as: clinical trial protocols, informed consent forms, investigator brochures, clinical study reports, data management plans, reconciliation guidelines, and safety report forms for assigned studies
- Manage the preparation, revision, and stakeholder review of safety management plans (operational safety agreement with Drug Safety vendor) for assigned studies
- Responsible for ensuring the Drug Safety vendor’s day-to-day case intake, processing, and submission/exchange activities, ensuring high-quality ICSRs in the Denali global safety database and adherence to agreed processing timelines to support compliance in ICSR submissions and exchange
- For assigned areas of responsibility, identify and escalate trends or issues in vendor performance to the Director, Drug Safety Operations based on routine oversight of the vendor’s activities, vendor-generated operational/compliance reports or metrics, feedback from other functional stakeholders, etc.
- When required, serve as a Drug Safety Operations subject matter expert (SME) for inspections and audits, and support department/company inspection and audit readiness initiatives
- Assist in Drug Safety quality assurance activities, including review and tracking of deviation reports, quality events, and corrective and preventative actions (CAPAs)
- Contribute to the set-up and maintenance of Drug Safety document repositories and document sharing platforms; ensure timely document uploading, filing, and archival to support compliance and inspection readiness
- Maintain the Drug Safety team’s master calendar and dashboard
- Other duties as assigned, including continued process improvement
Requirements
- Bachelor’s degree in a life science or healthcare-related discipline, or equivalent required
- 5+ years of relevant clinical drug safety/pharmacovigilance experience within the pharmaceutical or biotech industry, including 2+ years of vendor oversight experience required
- Drug safety database (Argus or ARISg) experience required
- Direct experience with Health Authority inspections preferred
- Expert knowledge of global regulatory pharmacovigilance requirements and guidelines (e.g., ICH, FDA, GVP)
- Thorough understanding of the pharmaceutical drug development process
- Excellent verbal, written communication, and interpersonal skills
- Ability to efficiently perform multiple tasks and manage changing priorities
- Ability to proactively identify and solve logistical problems
- Proficiency in Microsoft Word, PowerPoint and Excel
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state or local protected class.
Salary Range: $148,000 to $177,333. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
*This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
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