Full-Time
Director – Pharmacovigilance
Posted on 1/24/2023
Pioneering precision genetic medicines through CRISPR base editing
Senior, Expert
Cambridge, MA, USA
- Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV
- 10+ years' pharmaceutical industry experience, including a minimum of 5 years' experience in PV
- Knowledge of MedDRA terminology and its application
- Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data
- Experience in the preparation and authoring of pre- and post- aggregate safety reports
- Thorough understanding of the drug development process and context applicable to safety surveillance activities
- Ability to execute and follow-through to completion and documentation
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
- Independently motivated, detail oriented and good problem solving ability
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
- Excellent communication skills and ability to influence across multiple functions
- Be ready to embrace the principles of Beam
- Oversight of day to day safety monitoring activities and safety operations of clinical trials for the assigned product
- Provide PV subject matter expertise on Clinical Development Teams and other cross-functional platforms throughout the company
- Facilitate internal cross-functional Safety Management Committee meetings; includes coordinating materials, data presentation and all outputs, and agenda
- Review and provide PV input for development of protocols, IBs, CSRs and other relevant study documents
- Project lead for DSURs and subject matter contributor to other aggregate documents such as Investigator Brochure
- Oversight of vendor specific to PV deliverables
Beam Therapeutics, established in 2018, is a pioneer in the field of genetic medicine, utilizing CRISPR base editing to create precise, permanent alterations to single bases in DNA and RNA without breaking the strands. The company's culture is characterized by a community of fearless innovators, rigorous and honest research, open-mindedness, and commitment to each other. Their competitive advantage lies in their unique delivery strategy, which includes a range of clinically validated technologies such as electroporation, nonviral, and viral delivery modalities, positioning them as a leader in the genetic medicine industry.
Company Stage
IPO
Total Funding
$689M
Headquarters
Cambridge, Massachusetts
Founded
2017