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Job Details

Exception Template - Pharmacovigilance Sr. Scientist

Company name
Aequor, Inc.

Location
Thousand Oaks, CA

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Onsite at Thousand Oaks or Cambridge, MA

Peferred:

RN, PharmD or PA Clinical/medical research experience Processes and regulations for pharmacovigilance and risk management Aggregate data analysis, interpretation and synthesis Signal detection, evaluation and management 6 years of experience in a biotech/pharmaceutical setting

Description

Job Summary: The PV Sr. Scientist works with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. Key Activities: Applicable tasks may vary by product(s) assigned. The PV Sr. Scientist is responsible for the following: • Planning, preparation, writing and review of portions of aggregate reports • Organize and direct liaison for activities with affiliates and other internal Client partner regarding products • Supports and provides oversight to staff with regards to safety in clinical trials to: o Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents • Review of AEs/SAEs from clinical trials as needed • Review standard design of tables, figures, and listings for safety data from clinical studies • Participate in development of safety-related data collection forms for clinical studies • • Signal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis results • Documents work as required in the safety information management system • Support authoring of Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO • Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection • Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body • Assist GSO in the development of risk management strategy and activities: o Provides contents for risk management plans o Develop or update strategy and content for regional risk management plans o Assist GSOs to oversee risk minimization activities including tracking of activities as needed. o Evaluate risk minimization activity o Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO • Support activities related to new drug applications and other regulatory filings o Assist GSO in developing a strategy for safety-related regulatory activities o Provide safety contents for filings Inspection Readiness • Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness • Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

Knowledge and Skills: • Processes and regulations for pharmacovigilance and risk management • Drug development and lifecycle management • Safety data capture in clinical development and post-market settings • Safety database structure and conventions • MedDRA and other dictionaries used in pharmacovigilance • Methods of qualitative and quantitative safety data analysis • Product and disease state knowledge • Risk management and risk minimization • Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and product labeling • Advanced understanding of interfaces across various pharmacovigilance and risk management processes • Internal organizational and governance structure Pharmacovigilance skills-intermediate knowledge of the following: • Signal detection, evaluation and management • Aggregate data analysis, interpretation and synthesis • Good clinical and scientific judgment • Application of medical concepts and terminology • Document writing and source document review • Writing Risk Management Plans • Ability to convey complex, scientific data in an understandable way • Ability to analyze and interpret complex safety data • Intermediate skills in application of statistical and epidemiological methods to pharmacovigilance Biomedical Literature-intermediate skills: • Literature Surveillance: source document review knowledge and skills • Literature search, evaluation and assessment skills-ability to search literature databases to identify safety literature for signal evaluation and assessment, interpretation and synthesis skills Other skills-intermediate skills in the following: • Organization, prioritization, planning skills • Collaboration with cross-functional team settings • Meeting management and time management skills • Process and project management • Critical scientific assessment and problem solving • Strong Written and verbal communications skills, including medical/scientific writing • Computer skills (e.g., MS Office Suite and safety systems) • Strategic thinking • Influencing and negotiation in a cross-functional, matrix environment • Presentation skills for conveying complex technical contents to non-expert audiences

KNOWLEDGE: • Broad PV knowledge with expertise within defined subject area • Applies knowledge and broad understanding of multiple disciplines • Understands impact of emerging scientific/technical trends and their implications for Client PROBLEM SOLVING: • Analyzes and forecasts scientific/technical trends • Develops solutions to problems through in-depth analysis, coordination and negotiation with key decision makers • Performs complex work-flow analysis on processes impacting multiple areas across the organization • Adapts and integrates own experience with Client-wide strategy • Develops innovative solutions to problems without precedent • Proposes new processes to achieve strategic business objectives • Works in partnership with GPS team to develop business plans that support the direction of the business AUTONOMY: Guided by business plans and strategy: • Executes strategy, goals and changes within area of responsibility • Contributes to strategic decisions affecting the discipline • Guides ideas through development into a final product CONTRIBUTION: • Contributes to business results through quality of results, advice and decisions related to the operations of the discipline • Designs and develops global processes, systems and/or applications • Contributes to organizational through leadership • May accomplish business results through leveraging a team of professionals and/or managers • Develops mutually beneficial strategic alliances with internal and external contacts Education & Experience (Basic): Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree and 8 years of directly related experience OR Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience Education & Experience

Company info

Aequor, Inc.
Website : http://www.aequor.com/

Company Profile
Aequor Technologies is an IT solutions and consulting company serving businesses of all sizes across a broad spectrum of industries and sectors. We combine cutting-edge IT expertise with personalized service and customized solutions not always available from larger entities.

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