Clinical - Pharmacovigilance (PV) Scientist

1 month ago


Madison, United States TechDigital Corporation Full time
Position is Onsite

Functional Area Description
The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.

Position Summary / Objective
Support Medical Safety Assessment Physicians (MSAP) in leading Safety Data Review (SDR) Teams. Appropriately perform core signal detection activities and elevate program or portfolio issues impacting key MST programs, priorities, resources, and milestones with appropriate oversight. Author responses for safety data queries and contribute to specified PV sections of the Periodic Benefit Risk Evaluation Report (PBRER) and Development Safety Update Report (DSUR). Ensure pharmacovigilance regulatory compliance with oversight, as needed.

Position Responsibilities
• Lead Safety Data Review (SDR) Teams and participate in related PV and product-development subteam(s). Appropriately elevate signal detection findings impacting key MST activities, milestones, and documents to the MST Chair. Support individuals in aspects of project management, drug development and MST requirements, as appropriate to meet overall MST/subteam needs.
• Author and contribute to specified PV sections of the PBRERs and DSURs with oversight, as needed
• Author responses to safety data queries from health authorities including coordination and integration of scientific, medical, and regulatory input from a variety of scientific sources and functional groups, as needed to support responses to safety data/ad hoc queries and HA requests.
• Perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data.
• Collaborate within and across Client functions with appropriate disciplines to identify and ensure management of internal and external documentation and support when required.
• Apply knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities. Share with individuals and teams on these applied learnings.

Experience Requirements:
Minimum of 3 to 5 years BS/RN; 1 to 3 years MS/PharmD/PhD/MD, or equivalent relevant Pharmaceutical Industry experience; Demonstrated ability to mentor and coach others.

Key Competency Requirements
• Working understanding of medical concepts and some familiarity with safety activities in drug development and postmarketing and global safety health authority requirements.
• Working understanding of team priorities and milestones. Ability to manage timelines and quality of work using organizational and interpersonal communication skills. Appropriately communicates items that could impact timelines or quality.
• Ability to work well in cross-functional teams.
• Good collaborative and communication skills with scientific subject matter.
• Attention to detail along with strong scientific, analytical and conceptual skills and the ability to reach reasoned conclusions. Ability to understand complex medical-scientific data from a broad range of disciplines (eg, clinical trial laboratory data, nonclinical data, postmarketing reports, scientific literature, and regulatory documents).
• Understand aspects and methods for data analysis, interpretation and presentation.
• Possess good working skills in MS Word, Excel and PowerPoint, including statistics

  • Madison, United States TechDigital Corporation Full time

    Position is Onsite Functional Area Description The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco–epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit–risk...


  • Madison, United States TechDigital Corporation Full time

    Position is Onsite Functional Area Description The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco–epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit–risk...


  • Madison, United States Bristol-Myers Squibb Full time

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...


  • Madison, United States Exact Sciences Full time

    JOB REQUIREMENTS: Summary of Major Responsibilities The Clinical Laboratory Scientist I performs laboratory analysis on clinical specimens using established laboratory procedures. The Clinical Laboratory Scientist I duties will include but are not limited to; processing of specimens, performance of moderate, and highly complex analytical testing,...


  • Madison, United States Exact Sciences Full time

    JOB REQUIREMENTS: Summary of Major Responsibilities The Clinical Laboratory Scientist I performs laboratory analysis on clinical specimens using established laboratory procedures. The Clinical Laboratory Scientist I duties will include but are not limited to; processing of specimens, performance of moderate, and highly complex analytical testing,...


  • Madison, United States Exact Sciences Full time

    JOB REQUIREMENTS: Help us change lives At Exact Sciences, we\'re helpingchange how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life...


  • Madison, United States Exact Sciences Full time

    JOB REQUIREMENTS: Help us change lives At Exact Sciences, we\'re helpingchange how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life...


  • Madison, United States Exact Sciences Corporation Full time

    **Help us change lives** At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re...


  • Madison, United States Exact Sciences Full time

    Help us change lives At Exact Sciences, we're helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working...


  • Madison, United States Exact Sciences Full time

    Help us change lives At Exact Sciences, we're helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working...


  • Madison, United States Arrowhead Pharmaceuticals, Inc. Full time

    The Position The Senior Scientist will be part of a team responsible for the delivery of translational biomarker strategies for drug development candidates. The ideal candidate will possess a strong background in biological sciences, in-depth experience in translational research/medicine and clinical biomarkers in drug development. He/she will also have...


  • Madison, United States Arrowhead Pharmaceuticals, Inc. Full time

    The Position The Senior Scientist will be part of a team responsible for the delivery of translational biomarker strategies for drug development candidates. The ideal candidate will possess a strong background in biological sciences, in-depth experience in translational research/medicine and clinical biomarkers in drug development. He/she will also have...


  • Madison, United States Exact Sciences Full time

    Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re...


  • Madison, United States Promega Full time

    JOB OBJECTIVE: Supports global customers in using Short Tandem Repeat (STR) products and services outside of forensics and paternity. The position covers technical reagent workflows, Capillary Electrophoresis, and data analysis for different segments in North America such as pharmaceuticals, biotechnology, academia and clinical. CORE DUTIES: Field Demo and...


  • Madison, United States Promega Full time

    JOB OBJECTIVE: Supports global customers in using Short Tandem Repeat (STR) products and services outside of forensics and paternity. The position covers technical reagent workflows, Capillary Electrophoresis, and data analysis for different segments in North America such as pharmaceuticals, biotechnology, academia and clinical. CORE DUTIES: Field Demo and...


  • Madison, United States SSM Health Full time

    **It's more than a career, it's a calling.** WI-SSM Health Dean Medical Group South Madison Campus **Worker Type**: Regular **Job Summary**: Under general direction, interprets and reports test results. Performs routine and complex technical laboratory analyses using established procedures and protocols. Performs chemical, microscopic, and bacteriologic...


  • Madison, United States SSM Health Full time

    **It's more than a career, it's a calling.** WI-SSM Health Dean Medical Group 1821 S Stoughton Rd **Worker Type**: PRN **Job Summary**: Under general direction, interprets and reports test results. Performs routine and complex technical laboratory analyses using established procedures and protocols. Performs chemical, microscopic, and bacteriologic tests...


  • Madison, United States LabCorp Full time

    Imagine being involved in cutting edge technology and projects that change the course of our industry on a daily basis. At Labcorp, one of the world's largest and most comprehensive pharmaceutical solutions service companies, you will have an opportunity to build an exciting career while you make a direct impact on the lives of millions. We have a unique...


  • Madison, Wisconsin, United States Labcorp Full time

    Imagine being involved in cutting edge technology and projects that change the course of our industry on a daily basis. At Labcorp, one of the world's largest and most comprehensive pharmaceutical solutions service companies, you will have an opportunity to build an exciting career while you make a direct impact on the lives of millions.We have a unique...


  • Madison, United States Barrington James Full time

    Company Overview: We are a leading biopharmaceutical company dedicated to advancing the field of cell metabolism and developing innovative therapies across oncology and inflammation. Our mission is to transform patient care through the discovery and development of groundbreaking treatments that target key pathways of the immune system. Position Summary: We...