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Keros Therapeutics is a public, clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need. We are a leader in understanding the role of the transforming growth factor-beta, or TGF-, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. We have leveraged this understanding and developed a discovery approach to generate large and small molecules to address diseases of these tissues. Targeting TGF- signaling pathways has been clinically proven to elicit robust changes in blood cells, muscle, and bone, which we believe provides a precedent and strong rationale for our strategy.
This person will report to the Executive Director of Pharmacovigilance and supports both early and late-phase development activities. PV Scientist partners with PV physicians, other clinical development colleagues, and PV vendors, and will contribute to safety deliverables required to manage and communicate the evolving safety profile.
This role is responsible for performing core pharmacovigilance activities in partnership with the PV Physician and Study Physician by supporting the process for safety signal management activities and analyses, aggregate report contributions, responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial activities including data cleaning.
PV Scientist partners with the PV physician to provide scientific/clinical expertise, strategic input, and support for deliverables and activities associated with signal management activities, management of potential safety issues, evaluation of databases for safety signals, and drafting of responses to regulatory inquiries/ IRB/ EC requests on product safety issues for assigned product(s) during all phases of the product life-cycle. PV Scientist provide support to PV Physician in activities relating to monitoring and management of emerging safety profiles for assigned product(s). This person also prepares materials (Slides, etc.) in preparation for safety committees such as Safety Management Team and DSMBs.
Key Responsibilities:
- Signal detection, evaluation, and management from clinical trials - Perform data analysis to evaluate safety signals and write up/ present analysis and results
- Collaborate with other applicable functional areas, including but not limited to Biostatistics, Clinical, Quality, Regulatory Affairs to identify, evaluate and manage safety signals
- Assure oversight for the review of safety events to ensure accuracy, integrity, and completeness of safety information, and to ensure consistency of medical coding of safety data
- Provide content for safety sections of clinical documents such as Investigator's Brochure (IB) safety risk sections, informed consent form (ICF) safety risk section, clinical study reports, statistical analysis plans, and other clinical study-related documents to ensure alignment with the safety strategy and risks
- Represent PV on the clinical study team(s) to support the safety content for study document such as protocol, ICF, safety management plans, eCRFs, reconciliation plans, etc
- Direct the planning, preparation, writing, and review of aggregate reports (e.g., DSURs) and risk management plans
- Prepare the safety responses to Health Authority/IRB/EC requests and questions
Education & Qualifications:
- Ph.D., RN, PharmD, or MD degree required
- Minimum of 3-5 years of experience as pharmacovigilance scientist
- Experience in safety signal detection, evaluation, data analysis, and interpretation
- Excellent communication skills, both written and verbal
- Knowledge of MedDRA and WHO-Drug dictionaries
- Experience using analytics tools (such as Spotfire) preferred
- Experience in Oncology drug development is preferred
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Our Diversity, Equity & Inclusion Mission Statement: Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.
Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.