Pharmacovigilance Safety Scientist (2018-29252)

Comrise Horsham , PA 19044

Posted 3 months ago

Job Description


The Scientist will be responsible for assigned tasks related to core safety deliverables including scheduled and ad hoc aggregate reports and will serve as report owner for assigned reports (small to medium volume, standard complexity). Daily activities involve planning, conducting meetings, database searching, aggregate safety analysis and case level review, writing, and project management/coordination of strategic safety documents. The Scientist will partner with team members, stakeholders, and a vendor.


85% of the time:

Ensure timely, quality deliverables for assigned tasks related to core deliverables with oversight as appropriate

Collaborate with PVER team members to perform assigned tasks, Interact with other stakeholders (e.g Safety Surveillance Physician (SSP), Medical Safety Officer (MSO)) on relevant deliverables

Initiate/conduct searches of internal and external databases

Perform aggregate safety analysis and case level review

Author/contribute to the preparation of core safety deliverables

Ensure commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met as appropriate for assigned tasks

Partner with vendor to develop reports/deliverables

15% of the time:

Training/Meetings/Department Initiatives

Participate in department training

Training of task or process-related activities

Participate in department initiatives as appropriate


Bachelors Degree in Health or Biomedical Science (3-5 years industry experience or equivalent)

Advanced Degree Preferred in Health or Biomedical Science (2 years industry experience or equivalent)

Clinical/Medical writing or PV experience preferred

Strong English verbal and written communication skills


Scientific Skillset: Analytic and Conceptual Skills

Independence: Minimal independence; (Contributor/Co-lead)

Knowledge (Product and Regulations): Safety Management Team (SMT) support when needed

Awareness of applicable global, regional, and local regulatory requirements (e.g., ICH guidelines)

Company Description

Comrise is the bridge to first-rate talent for organizations that recognize the value of their workforce. With locations in the U.S., China, and Hong Kong, we help our clients reach far and wide for both local and international resources which yield the highest return on their human capital investments.Headquartered in New Jersey since 1984, Comrise is a staffing, consulting and enhanced search technology company. For over 30 years we have delighted our clients and consultants by focusing on customer satisfaction, innovation and flexible workforce solutions. By combining our global networks with our outstanding local offices, Comrise provides high quality executive search, temporary and temporary to permanent staffing solutions, and cross border placement services.
Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Signal Management Scientist

Johnson & Johnson

Posted 3 days ago

VIEW JOBS 7/16/2018 12:00:00 AM 2018-10-14T00:00 Janssen PharmaceuticalResearch & Development, L.L.C., a member of the Johnson & JohnsonFamily of Companies, is recruiting for a Signal Management Scientist. Thisposition will be based in Horsham, PA, Raritan, NJ, or Titusville, NJ. At the Janssen PharmaceuticalCompanies of Johnson & Johnson, what matters most is helping people livefull and healthy lives. We focus on treating, curing and preventing some of themost devastating and complex diseases of our time. And we pursue the mostpromising science, wherever it might be found. Janssen Research &Development, LLC discovers and develops innovative medical solutions to addressimportant unmet medical needs in oncology, immunology, neuroscience, infectiousdiseases and vaccines, and cardiovascular and metabolic diseases. Pleasevisit for more information. We are Janssen. Ourmission drives us. Our patients inspire us. We collaborate with the world forthe health of everyone in it. Thriving on a diversecompany culture, celebrating the uniqueness of our employees and committed toinclusion. Proud to be an equal opportunity employer. The objective of Signal Management Scientist is to implementSignal Management Group (SMG) surveillance strategies for proactive andsystematic detection and evaluation of new safety signals and emerging trendsfrom pre and post marketing safety data. These activities include theevaluation (and piloting) as well as use of novel, computer-assisted tools andmethodologies for analysis of internal company safety data, internationalregulatory safety databases, and other data sources, e.g. claims and electronicmedical records and social media. This position, in partnership with other SMG physicians andscientists, develops and implements product-specific surveillance plans,performs signal detection activities, including signal validation, andparticipates in communication of emerging signals in forums, such as theProduct Team Meeting, Signal Management Teams, and monthly Product QualityMeetings. This position will also participate in the development of strategiesfor signal evaluation, and may include performing activities supporting signalevaluation, such as case definition development (including database querycriteria), review of the signal tracking system, ad hoc data mining FAERS,Vigibase, and SCEPTRE, and text mining. Responsibilities: * Identify and assess (validate) newsafety signals and trends by conducting systematic reviews of aggregate datawith a focus on spontaneous adverse event reports. This includes signaldetection activities in safety platforms, including SMART, routine and ad hocdata mining in Empirica Signal, and signal entry to Empirica Topics. * Prepare reviews of topics and summaryanalysis reports of safety data, in consultation with the SMG physicians.Provide recommendations for further evaluation. * Work with key customers and business partners (MSOs, PVERs, andSSPs) in developing and implementing product specific pharmacovigilance plans. * Participate as member of the matrixteams to address product specific safety issues, assist in the development ofsignal evaluation strategies, and participate in signal evaluation, includingliterature reviews. Communicate findings from routine and ad hoc signaldetection and assessment activities. * Assist in the development andimplementation of programmatic surveillance of adverse event reports forpotential safety and product quality issues. * Assist in the evaluation of novel,computer-assisted tools and methodologies for analysis of safety data,including piloting new data source and methodologies. * A minimum of an advanced degree in a health-care discipline (RN, MSc,M.P.H., etc) is required. A doctoraldegree in the above is preferred but not required (e.g.Pharm.D. PhD). * A minimum of 3 years of experience in post-marketing safety dataanalysis is required * Familiarity with safety analysis, including case definitiondevelopment, case series analysis, and literature review is required * An understanding of global health authority regulations andguidances surrounding the processing, reporting and evaluation of adverseevents is preferred * Good understanding in single case processing, aggregate datareview and evaluation of drug safety issues, knowledge of adverse eventdictionaries, core labeling, preparation and review of Periodic Safety Revieware required * Ability to present complex data in a concise and understandablescientific manner is essential. * Ability to manipulate data in platforms such as Excel and SAS JMPis required. Johnson & Johnson Horsham PA

Pharmacovigilance Safety Scientist (2018-29252)