Safety Associate

**Who are we? **:**Amaris Consulting** is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 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 7,600 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 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: 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
**Job description**:
**Key Responsibilities**:

- Conduct medical analysis of adverse event reports and signal detection for assigned vaccine projects in clinical development and post-licensure.
- Serve as the safety contact for Clinical, Regulatory Affairs, regional, and local safety managers.
- Provide medical input on safety aspects in the design and preparation of clinical protocols, investigator brochures, and reports.
- Conduct Benefit-Risk Assessments and manage risk identification, assessment, and mitigation for vaccine projects.
- Lead the Safety Review Team and participate as a member of the Vaccine Leadership Team (VLT) for assigned projects.
- Develop and revise pharmacovigilance processes and training materials.
- Respond to inquiries from regulatory authorities regarding safety aspects of the projects.
- Ensure compliance with applicable regulations and participate in safety-related interactions with external collaborators.

**Required Profile**:

- Medical Doctor with a preferred specialization in Infectious Diseases, Epidemiology, or Vaccines.
- Minimum 3 years of post-registration clinical experience and at least 2 years in Pharmacovigilance within the Pharmaceutical or Biotech industry.
- Strong knowledge of Pharmacovigilance tools, signal detection, and safety reporting for vaccines.
- In-depth understanding of the regulatory environment, including International, US, and European legislation.
- Excellent understanding of the vaccine development process and safety regulations.
- Proven ability to manage crises, monitor safety issues, and work effectively under pressure.
- Strong analytical skills with attention to detail and the ability to prioritize tasks.
- Excellent English communication skills (written and spoken); French is a plus but not mandatory.
- Computer literate and familiar with scientific and clinical databases.

**Complexity**:

- Ability to make independent clinical assessments and decisions in a complex, multinational study environment.
- Ability to provide scientifically-based safety assessments within a complex public environment.

**What We Offer**:

- Fully Remote Opportunity