PV Scientist

Edgewise Therapeutics•Boulder, CO

13d•$135,000 - $175,000

About The Position

Pharmacovigilance and patient safety are a key part of Edgewise's strategy and are critical to our success. Edgewise Therapeutics executes clinical trials in partnership with Contract Research Organizations (CROs), Academic Research Organizations (AROs), and other service providers. Edgewise believes the ability to manage and collaborate with such entities is a core competency that can determine success or failure of clinical trial activities and indeed, the company. Reporting to the Head of Pharmacovigilance, the Safety Scientist will be responsible to perform safety assessments for Company’s Asset across all indications. This individual will work with Pharmacovigilance MDs and provide scientific/clinical expertise, strategic input, support for deliverables and activities associated with signal management, safety, and benefit-risk evaluations for Company Asset. The ideal candidate will manage potential safety issues for Company Asset, evaluate data for safety signals, and help draft responses to regulatory inquiries on product safety issues. This role provides an excellent opportunity for close collaboration with colleagues from other functions such as Clinical Development, Clinical Operations, Regulatory Affairs, and Medical Affairs.

Requirements

Healthcare professional or advanced degree (PharmD, PhD, RN, RPH, MS, MPH) required.
Minimum 7+ years relevant medical, scientific/clinical, or pharmaceutical experience, including experience in drug safety data analysis
Experience in signal detection with demonstrated experience in analysis and interpretation of medical and scientific data
Experience in safety data analysis and writing study-related aggregate reports (IB, DSUR, PBRER etc.) and safety assessments
Skilled at clearly communicating the insights as well as the implications and recommendations distilled from the analysis
Demonstrated ability to work effectively in a cross-functional team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as independently.
Excellent communication, oral and written, including medical / scientific writing
Knowledge of regulations and guidance (US and global) governing pharmacovigilance practices.
Sound understanding of PV safety surveillance activities.
Experience in MedDRA coding and search strategies.
Strong knowledge/proficiency in Microsoft Office Suite and safety database use.
Knows when and how to speak up and appropriately raise issues to the team and propose solutions to management.

Nice To Haves

Independent working style with high self-motivation to attain team goals in a fast-paced environment
Excellent interpersonal, analytical, computer, and oral and written communication skills.
Ability to facilitate analysis and problem solving through the effective facilitation of groups
Thoughtful collaborator with the ability to work effectively with internal and external stakeholders
Strategic, with an ability to incorporate new data into safety and risk assessments
Strong organizational and time management skills and the ability to function effectively in a team/matrix environment
Demonstrated professionalism and adherence to high ethical standards
Is proactive, a fast-learner, is flexible and adept at working in a fast-paced, changing environment with strong problem solving and analytical skills

Responsibilities

Responsible for compiling aggregate safety reports for Company Asset (e.g. DSUR, PBRER, PSUR) including safety database requests, working with safety physician and ensuring effective planning such that stakeholder input is requested/received for applicable sections of the report to meet regulatory timelines
Responsible for compiling safety information for clinical overviews, responses to regulatory questions, post-marketing safety assessment, risk management plans, labeling justifications, CCSI development, IB updates, label updates as well as written summaries of clinical safety of common technical documents
Collaborates with the safety physician for signal detection activities, including medical review and benefit-risk assessment of Company Asset
Manage literature review plan for marketed products and medicinal products under development
Responsible for ensuring efficient planning and execution of routine and ad-hoc Safety governance meetings in collaboration with the safety physician
Effectively collaborate with stakeholders outside of PV, including representing PV department in cross-functional clinical programs and registration activities
Works with CROs and clinical teams to ensure protocol designs enable timely processing and global regulatory compliance for all SAEs from assigned protocols
Provides oversight of SAE reconciliation activities between the clinical and safety databases in accordance with SOPs
Collaborates with Clinical Operations, Data Management, CRO and Study Teams in development of the safety-related, table design, and listings for safety data from interventional/non‐interventional trials and safety reporting plans (SRP)
Lead/Assist in developing, implementing, and supporting policies, standard operating procedures (SOPs), tools, etc., pertaining to pharmacovigilance activities when needed
Responsible for project managing and authoring of safety documents in collaboration with safety physicians