Pharmacovigilance Scientist
Company: Aerotek
Location: Summit
Posted on: April 10, 2021
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Job Description:
Description:Sr. Manager PV Scientist (Contractor)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.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.General Product Support* Supports Medical
Safety Assessment Physician (MSAP) leading signal detection
activities for a product's emerging safety profile.* Prepare/write
PV sections of aggregate safety documents (eg, DSUR, PBRER) and
analyze data for the RSI section of the IB. Write and analyze data
for ad hoc responses to health authorities, with oversight.*
Execute strategy for signal evaluation (eg, case-series, literature
review, HA/ claims database). Document signal by Safety Topic
Review/ Signal Report.* Analyze data and prepare documentation to
support label updates for assigned products, with oversight.*
Support Safety input for regulatory product labeling.* Support the
EU QPPV or other regional or local Qualified Person for safety
issues relating to assigned products.* Working 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.Clinical Development & Post Marketing Product Support*
Perform core surveillance activities, signal assessment according
to the product stage of development for a multiple compounds, with
oversight, as needed.* Lead Safety Data Review Meetings (SDRM) in
the review and evaluation of clinical data to support signal
detection. Appropriately elevate issues impacting key SMT
activities, milestones, and documents to the SMT Chair with
oversight, as needed.* Contributes to specified PV sections of the
DSURs, PBRERs and safety data query responses to HAs including
coordination and integration of input from other functional groups,
as needed to support responses to ad hoc queries, with oversight,
as needed.* Perform periodic review and summary of pertinent
safety-related literature and analysis of pre-determined core
signal data.* Executes the strategy for signal evaluation (eg,
case-series, literature review, HA/ claims database). Partner with
SMT Chair on the evaluation & management of signals emerging from
any data source. Authors the Safety Topic Review/ Signal Report and
tracks signals for other means of communication, with oversight, as
needed.* Perform the review and evaluation of SARs for inclusion in
the IB RSI, including presentation to SMT to ensure alignment.
Author the IB RSI table, for less complex products with oversight,
as needed.* Author documentation to support safety labeling updates
to ensure labeling adequately reflects the emerging postmarketing
safety profile, with oversight as needed.Scientific degree (e.g.,
BS, MS, RN, PharmD, PhD, MD) or other degree with the equivalent
combination of relevant education and professional experience.3 - 5
years relevant Pharmacovigilance/Pharmaceutical Industry
experience.* 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. * Adaptable /
flexible (willing and able to adjust to multiple demands and
shifting priorities; ability to meet day-to-day challenges with
confidence and professionalism)* 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 statisticsExperience
Level:Intermediate Level About Aerotek:We know that a company's
success starts with its employees. We also know that an
individual's success starts with the right career opportunity. As a
Best of Staffing Client and Talent leader, Aerotek's people-focused
approach yields competitive advantage for our clients and rewarding
careers for our contract employees. Since 1983, Aerotek has grown
to become a leader in recruiting and staffing services. With more
than 250 non-franchised offices, Aerotek's 8,000 internal employees
serve more than 300,000 contract employees and 18,000 clients every
year. Aerotek is an Allegis Group company, the global leader in
talent solutions. Learn more at Aerotek.com.The company is an equal
opportunity employer and will consider all applications without
regards to race, sex, age, color, religion, national origin,
veteran status, disability, sexual orientation, gender identity,
genetic information or any characteristic protected by law.
Keywords: Aerotek, New York , Pharmacovigilance Scientist, Other , Summit, New York
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