2 PV Scientist Jobs in Cambridge, MA
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PV Scientist
$98k-126k (estimate)
Full Time | Business Services
1 Week Ago
LanceSoft Inc is Hiring a PV Scientist Near Cambridge, MA
SummaryContribute as a member of the Drug Safety team to scenario planning, strategy analysis, portfolio prioritisation, budget management and forecasting.
Document Management and Authoring for aggregate safety reports (eg.PSUR, DSUR, Line listings) in close collaboration with the safety product lead and operational functions
Safety Risk Management Team slide preparation
Works closely with the safety physician to analyze potential safety issues, including signal detection, signal evaluation and signal management. Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas.
Contribute to signaling and data mining activities utilizing internal and external sources of data. Performs signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA requests
Assist in the evaluation of potential safety issues and quality risk assessment reports.
QualificationsEducation: Degree in a medical or healthcare related discipline ( MSN RN, PharmD, Physician Assistant) is required
Experience: A minimum of five to seven years in the pharmaceutical industry with experience in drug safety/pharmacovigilance. Document Management and use of VEEVA preferred. Specific experience in RNA therapeutic area at a global level is an advantage.
Strong Skills And Experience InSupporting the development and application of business process improvement methodologies and/or developing ideas into practical business solutions.
Ability to manage teams and to work in a matrix environment in accordance with the company leadership commitments and values. Preferably with experience of working across diverse geographic areas, business settings and cultures.
Pharmacovigilance, safety or clinical science, and/or other relevant areas of clinical biopharmaceutical development or medical affairs.
Knowledge of Argus Safety Databases
Knowledge of Signaling tools (eg. Empirica)
Advanced knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements
Strong planning, organization, written and oral communication skills
Document Management and Authoring for aggregate safety reports (eg.PSUR, DSUR, Line listings) in close collaboration with the safety product lead and operational functions
Safety Risk Management Team slide preparation
Works closely with the safety physician to analyze potential safety issues, including signal detection, signal evaluation and signal management. Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas.
Contribute to signaling and data mining activities utilizing internal and external sources of data. Performs signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA requests
Assist in the evaluation of potential safety issues and quality risk assessment reports.
QualificationsEducation: Degree in a medical or healthcare related discipline ( MSN RN, PharmD, Physician Assistant) is required
Experience: A minimum of five to seven years in the pharmaceutical industry with experience in drug safety/pharmacovigilance. Document Management and use of VEEVA preferred. Specific experience in RNA therapeutic area at a global level is an advantage.
Strong Skills And Experience InSupporting the development and application of business process improvement methodologies and/or developing ideas into practical business solutions.
Ability to manage teams and to work in a matrix environment in accordance with the company leadership commitments and values. Preferably with experience of working across diverse geographic areas, business settings and cultures.
Pharmacovigilance, safety or clinical science, and/or other relevant areas of clinical biopharmaceutical development or medical affairs.
Knowledge of Argus Safety Databases
Knowledge of Signaling tools (eg. Empirica)
Advanced knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements
Strong planning, organization, written and oral communication skills
Job Summary
JOB TYPE
Full Time
INDUSTRY
Business Services
SALARY
$98k-126k (estimate)
POST DATE
06/27/2024
EXPIRATION DATE
07/25/2024
WEBSITE
lancesoft.com
HEADQUARTERS
HERNDON, VA
SIZE
500 - 1,000
FOUNDED
2000
TYPE
Private
CEO
DIVYA GANDHI
REVENUE
$200M - $500M
INDUSTRY
Business Services
Related Companies
About LanceSoft Inc
LanceSoft is a provider of application development, management outsourcing and data-warehousing services to the aerospace and automotive sectors.
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