Company Overview:
Beam Therapeutics is committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.
Position Overview:
This is a unique opportunity to join a growing Pharmacovigilance team. This PV expert will start as an individual contributor and may have opportunity to grow his/her team over time. Responsibilities include providing strategic scientific and operational PV support for products in the Beam portfolio. The Director of Pharmacovigilance will contribute to a full range of pharmacovigilance activities including but not limited to the oversight and management of safety reports and safety data, signal management activities, PV organization and process development, inspection readiness, PV vendor management, and operational support for Beam products throughout the lifecycle. In addition, she/he will also function in a company matrix environment collaborating with several key groups including but not limited to Clinical Operations, Biometrics, Data Management, Clinical Development, Clinical Science, Regulatory Affairs, Medical Writing, Nonclinical, and Quality.
Responsibilities:
- Liaise with senior management and all levels of the organization to establish strategic plans and objectives in support of pharmacovigilance goals and initiatives.
- 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 forums throughout the company.
- Facilitate internal cross-functional Safety Management Committee and/or other safety governance/review meetings; including coordinating materials, data outputs and presentation, agenda and minutes.
- Ensure that safety reports for assigned products are triaged, processed and submitted/distributed as required per global requirements and applicable SOPs.
- Perform individual case safety report assessments for clinical trial safety reports, including review of Analysis of Similar Events, as applicable.
- Work closely with the Medical/Safety Lead to support signal detection activities, which may include: preparing signal assessment, tracking, and validation documents; leading cross functional teams to assess safety signals; preparing action and communication plans to mitigate/manage product risks; responding to safety related regulatory requests; developing and maintaining product risk management plans.
- Contribute to the development and maintenance of Reference Safety Information (RSI) including Company Core Data Sheet (CCDS), Company Core Safety Information (CCSI), Investigator Brochure (IB), and/or other product labeling.
- Project lead for DSURs, 6-monthly line listing reports or other aggregate safety reports, and oversee reporting compliance.
- Communicate with partner companies, vendors, and internal group regarding processing and timely exchange of safety reports.
- May perform and/or provide oversight for day-to-day interaction with PV vendor(s).
- Contribute to the development and review of clinical, regulatory, and scientific documents including clinical study protocols, informed consent forms, study plans, clinical study reports, manuscripts/journal articles, scientific abstracts/posters, case report forms, statistical analysis plans, and/or other documents as needed.
- Develop training materials and conduct training on PV related content, including presentations at Investigator Meetings and/or Site Initiation Visits, as needed.
- Lead process development to support pharmacovigilance risk management activities at the product and portfolio level.
- Participate in departmental and cross functional risk assessment and process improvement initiatives.
- Maintain knowledge of disease indications for assigned Beam products.
- Participate in the development of PV organizational strategy, goals, and objectives and assist with the implementation and training to support department goals and initiatives.
- Develop or support development of standard operating procedures (SOPs) and/or other process related documents e.g. Safety Management Plans, Work Instructions.
- Contribute to inspection readiness, audits, and compliance oversight activities.
- Support organizational leadership in assigned activities and initiatives and actively participate in daily pharmacovigilance activities with a "can-do, hands-on, positive attitude".
- Other duties, as assigned.
Qualifications:
- Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent degree with pharmaceutical industry background and proven competence in PV. Healthcare professional degree preferred (Nurse Practitioner, Physician Assistant, RN/BSN, Pharm D, MD, or equivalent)
- 10+ years’ pharmaceutical industry experience, including a minimum of 5 years’ experience in PV.
- Knowledge of MedDRA dictionary, clinical trial methodology, medical terminology, and general principles of clinical assessment of AEs
- Demonstrated knowledge of global PV regulatory environment with working knowledge of international regulations including but not limited to FDA, EU, GVP, ICH guidelines and regulations pertaining to clinical development and post-marketing safety environments
- Working knowledge of industry standard safety databases (ARGUS and ARISg) and other electronic data capture systems
- 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 navigate fast-paced and dynamic work environment; ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
- Ability to manage and prioritize multiple projects and demands simultaneously with ability to adjust to changing priorities and work effectively under pressure
- Excellent communication, interpersonal, and writing skills, including ability to work effectively cross-culturally and cross-functionally with internal and external stakeholders
- Independently motivated, detail oriented and good problem-solving ability.
- Excellent organizational and prioritization skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
- Strong organizational and project management skills
- Some international/domestic travel may be required
- Be ready to embrace the principles of Beam.
