Clinical - Pharmacovigilance (PV) Scientist Pharmacovigilance (PV) Scientist
Posted on: September 26, 2022
Pharmacovigilance (PV) ScientistJob Number: 22-05946 Be part of
a company that delivers life-changing healthcare solutions. Eclaro
is looking for a Pharmacovigilance (PV) Scientist for our client in
Summit, NJ. Eclaro's client is a leader in the Biopharmaceutical
Industry, providing quality, innovative, and affordable medicines
that make a difference in the lives of patients all over the world.
If you're up to the challenge, then take a chance at this rewarding
opportunity! Position Overview: 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.
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. Qualifications: 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. Required Skills: 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 If hired, you will
enjoy the following Eclaro Benefits: 401k Retirement Savings Plan
administered by Merrill Lynch Commuter Check Pretax Commuter
Benefits Eligibility to purchase Medical, Dental & Vision Insurance
through Eclaro If interested, you may contact:Paul
QuibuyenChristian.Quibuyen@eclaro.com6466952942Paul Quibuyen -
LinkedIn Equal Opportunity Employer: Eclaro values diversity and
does not discriminate based on Race, Color, Religion, Sex, Sexual
Orientation, Gender Identity, National Origin, Age, Genetic
Information, Disability, Protected Veteran Status, or any other
legally protected group status.
Keywords: Eclaro, New York , Clinical - Pharmacovigilance (PV) Scientist Pharmacovigilance (PV) Scientist, Healthcare , Summit, New York
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