Safety Associate
Job Description
The Safety Associate is expected to actively manage and evaluate risks associated with assigned vaccine projects, and make recommendations for the management and communication of risks in accordance with global legal and regulatory frameworks. This will involve working in partnership with the VCSP Safety Scientist to deliver the following:
• Coordinate and perform the medical analysis of adverse event reports and/or signal detection activities for assigned vaccine projects in clinical development and post-licensure
• Be the safety contact person for Clinical, Regulatory Affairs, regional and LOC (local operating company) safety managers, manufacturing teams for assigned vaccine projects
• Provide medical input to Clinical Teams with respect to safety aspects of the design and preparation of protocols, investigators brochures, investigator letters and reports, for the follow up and processing of clinical study data and lead the safety analyses of the assigned projects.
• Ensure creation, maintenance and implementation of (D)CSI (Development, Core Safety
Information) for the assigned projects.
• Ensure provision of the Benefit Risk Assessment and risk identification, assessment and
mitigation activities for assigned vaccine projects
ACCOUNTABILITY:
• Perform medical review and provide medical advice on safety-related aspects associated with the assigned vaccines.
• Signal detection and evaluation of safety for assigned projects.
• Manage the evolving safety profile of assigned vaccine projects
• Provide appropriate and timely Benefit Risk Assessments for assigned vaccine projects
• Design, tracking and follow up of risk management plans for the products assigned and assure their sound implementation.
• Lead the Safety Review Team and be VLT (Vaccine Leadership Team) member for assigned vaccine projects
• Development and revision of assigned central pharmacovigilance processes and related training.
• Answering and follow-up of enquiries from regulatory authorities and other bodies (e.g., Ethics Committees) regarding safety-related aspects.
• Implementation of the applicable regulations for the assigned vaccines.
• Participate in IDMC meetings or other safety related interactions with outside collaborators of the assigned vaccine projects.
• Implementation and follow-up of safety data exchange agreements for products assigned.
Your Profile:
• Medical Doctor with preferred specialism in Infectious Diseases, Epidemiology or Vaccines
• Minimum 3 years post-registration clinical experience
• 2+ years of experience in the Pharmaceutical or Biotech industry working in Clinical Development, Medical Affairs, Pharmacovigilance, Drug Safety or a related field.
• Knowledge of Pharmacovigilance and signal detection tools, analysis and reporting of medical safety issues for vaccines, taking into account the worldwide regulatory requirements.
• Knowledge and experience in collection and interpretation of Serious Adverse Events case reports.
• In depth understanding of the regulatory environment (e.g. International, US and European Legislation).
• Able to prioritise activities effectively and to meet multiple deadlines successfully with attention to detail, setting high performance standards for quality
• Fluency In English is mandatory
What we offer
At Keyrus, thanks to the expertise of our people and external partners, each employee is welcomed with a varied integration program. You will join a dynamic and international environment with enthusiastic and professional colleagues.
We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.
Who we are
Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
Workplace & Culture
Our offices are the place where you are always welcome when you are not working on client's site or from home. Every single person that joins us is met in a personal and unique way.
What is really common to all of us, is the envy to contribute to the improvement of people’s health. Every employee being part of Keyrus Life Science is therefore fully committed to making the world a better place to live.
With us, you will be part of our family and feel our human approach culture as of Day 1!
Safety Associate
Loading application form
Already working at Keyrus Life Science Belgium ?
Let’s recruit together and find your next colleague.