Executive Director - Pharmacovigilance

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Adverum Biotechnologies

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We are on a global mission to establish gene therapy as a new standard of care for highly prevalent ocular diseases.

Gene Therapy • Biotechnology • Rare Diseases • Ophthalmology • Retina

51 - 200

💰 $217M Post-IPO Equity on 2020-08

Description

• Adverum is seeking an Executive Director of Pharmacovigilance responsible for implementing and coordinating pharmacovigilance activities. • Actively participate in safety related aspects of the product life cycle from development to post-marketing. • Develop a proactive, forward-looking program of communicating safety information and directions for safety product use to stakeholders. • Ensure corporate compliance with domestic and international adverse event and safety issue reporting requirements.

Requirements

• MD, PharmD., RN, BSN, Nurse Practitioner, Pharmacist or related degree with at least 5+ years pharmaceutical industry, pharmaceutical industry safety surveillance, or applicable clinical/medical experience required. • Demonstrated knowledge of domestic and international ADE reporting regulations per guidelines and follow timelines as necessary for regulatory reporting purposes. • Demonstrated knowledge and proficiency with drug safety databases (i.e. ARISg or ARGUS) • Proficiency with standard office skills and standard desktop computing programs • Excellent oral and written communication skills with excellent interpersonal skills and willingness to work in a team environment, cross functionally, and work with multiregional organizations. • Highly organized and demonstrates understanding of workflow prioritization. • Ability to multitask and triage as needed with the ability to work independently, under pressure, demonstrating initiative and flexibility. • Excellent understanding of clinical trial methodology, GCP and medical terminology • Attention to detail and quality focused with strong technical and problem-solving skills • Strong organizational and project management skills • Strong communication skills and the ability to operate effectively in an international environment • Excellent understanding of physiology, pharmacology, clinical study objectives, and the drug development process • Strong computer skills including, but not limited to, creation of spreadsheets, templates, presentations and working with safety database applications.

Benefits

• 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.