Senior Manager, Pharmacovigilance

1 month ago

Lexington, United States Keros Therapeutics Full time

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

#LI-Hybrid

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