Be an early applicantLess than 25 applicants
BioSpace · 3 days ago
Pharmacovigilance Scientist, Senior Manager
Washington, DC
Full-time
Hybrid
Mid, Senior Level
Wonder how qualified you are to the job?
Maximize your interview chancesBiotechnologyCommunities
Insider Connection @BioSpace
Responsibilities
Directs the planning, preparation, writing and review of portions of aggregate reports
Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products
Supports and provides oversight to staff with regards to safety in clinical trials
Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents.
Review of AEs/SAEs from clinical trials as needed
Review standard design of tables, figures, and listings for safety data from clinical studies
Participate in development of safety-related data collection forms for clinical studies
Participate in study team meetings as requested or needed
Signal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis results
Documents work as required in the safety information management system
Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO
Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
Prepare presentation of the Global Safety Teams recommendations on safety issues to the cross-functional decision-making body
Assist GSO in the development of risk management strategy and activities:
Provides contents for risk management plans
Develop or update strategy and content for regional risk management plans
Assist GSOs with aspects of risk minimization activities including tracking of activities as needed.
Evaluate risk minimization activity
Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO
Support activities related to new drug applications and other regulatory filings
Assist GSO in developing a strategy for safety-related regulatory activities
Provide safety contents for filings
Inspection Readiness Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
Processes and regulations for pharmacovigilance and risk management
Drug development and lifecycle management
Safety data capture in clinical development and post-market settings
Safety database structure and conventions
MedDRA and other dictionaries used in pharmacovigilance
Methods of qualitative and quantitative safety data analysis
Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and product labeling
Pharmacovigilance Skills-intermediate Knowledge Of The Following Signal detection, evaluation and management
Aggregate data analysis, interpretation and synthesis
Application of medical concepts and terminology
Document writing and source document review
Writing Risk Management Plans
Ability to convey complex, scientific data in an understandable way
Ability to analyze and interpret complex safety data
Intermediate skills in application of statistical and epidemiological methods to pharmacovigilance
Biomedical Literature-intermediate Skills Literature Surveillance: source document review knowledge and skills
Literature search, evaluation and assessment skills-ability to search literature databases to identify safety literature for signal evaluation and assessment, interpretation and synthesis skills
Qualification
Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.
Required
Doctorate degree and 2 years of safety/pharmacovigilance related experience
OR
Masters degree and 6 years of safety/pharmacovigilance related experience
OR
Bachelors degree and 8 years of safety/pharmacovigilance related experience
OR
Associates degree and 10 years of safety/pharmacovigilance related experience
OR
High school diploma / GED and 12 years of safety/pharmacovigilance related experience
AND
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
Benefits
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Company
BioSpace
BioSpace is the leading online community for industry news and careers for life science professionals.
Founded in 1988
11-50 employees
H1B Sponsorship
BioSpace has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2020 (2)
Funding
Current Stage
Growth StageTotal Funding
$10M2000-08-24Series B· $10M
Leadership Team
J
Joshua Goodwin
CEO and President
K
Kristin Jones
Chief Revenue Officer
Recent News
2024-05-31
2024-05-05
2024-04-06
Company data provided by crunchbase
