Safety Scientist
il y a 1 semaine
Job Mission
As a Safety Scientist, you will collaborate with the Safety Evaluation and Risk Management (SERM) physician to actively manage and evaluate risks associated with assigned vaccine projects.
Your role will be crucial in making recommendations for the management and communication of risks in accordance with global legal and regulatory frameworks.
This mission involves coordinating and performing initial analyses of adverse event reports, conducting signal detection activities, and acting as the safety contact person for various stakeholders.
Key ResponsibilitiesPerform database searches to obtain information from the Safety Database.
Assist in reviewing aggregated adverse event reports for signal detection, evaluation, and management purposes for assigned vaccine projects.
Draft relevant clinical safety reports, including labeling documents, ad hoc reports, and position papers in collaboration with the safety physician.
Review protocols, study reports, IDMC charters, and operational activities associated with appropriate data provision and presentation of material.Contribute to timely Benefit Risk Assessments for assigned vaccine projects.
Design, track, and follow up on risk management plans, ensuring their sound implementation.
Review safety data from other databases, including literature reviews.
Summarize safety data for regulatory or clinical trial documents (e.g., ad-hoc queries, PBRERs, PSURs, and DSURs).
Address and follow up on inquiries from regulatory authorities and other bodies regarding safety-related aspects.
Lead or contribute to the cross-functional Safety Review Team for assigned vaccine projects.
Implement and follow up on safety data exchange agreements for assigned products.
Contribute to process improvement, documentation, and provide support for training stakeholders.
Generate reliable safety data from large, multinational study environments.
Provide scientifically based safety assessments within a complex public environment.
About You (Skills and Qualifications)
Hard Skills
Bachelor's degree or higher in a biomedical or healthcare-related specialty.
Basic understanding of safety evaluation methodology and awareness of pharmacovigilance regulations and methodologies.
Proficiency in medical terminology.
Experience in drafting responses to ad hoc queries or evaluating significant safety issues for regulatory submissions (e.g., PSURs) under supervision.
Clinical safety experience or equivalent experience in a pharmaceutical company, regulatory authority, etc.Computer literate, familiar with using scientific and clinical databases.
Good English writing skills.
Soft Skills
High degree of accuracy and attention to detail.
Methodical and analytical approach.
Strong communication skills and team spirit.
Flexibility and ability to manage crises and monitor safety issues under pressure.
Customer and solution-oriented approach.
Ability to prioritize activities effectively and meet multiple deadlines with high performance standards for quality.
Initiative and creativity in performing tasks and responsibilities, proactively contributing ideas to improve existing operations.
Who We Are
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses.
With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7500 people spread across 5 continents and more than 60 countries.
Our solutions focus on four different Business Lines:
Information System & Digital, Telecom, Life Sciences and Engineering.
We're focused on building and nurturing a top talent community where all our team members can achieve their full potential.
Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.Brief Call:
Our process typically begins with a brief virtual/phone conversation to get to know you The objective? Learn about you, understand your motivations, and make sure we have the right job for you
Interviews (the average number of interviews is - the number may vary depending on the level of seniority required for the position).
your line manager of course, but also other people related to your future role.
We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you.
Of course, you will also get to know Amaris:our culture, our roots, our teams, and your career opportunities
Case study:
Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
We look forward to meeting you
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