Safety Physician

One of our clients, an international company in the pharmaceuticalindustry currently requires a Safety Physician

Start: ASAP
Length: min 6 months + extended
Location: South of Brussels

Job Title: SERM (Safety Evaluation and Risk Management) Safety Physician

JOB PURPOSE:

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 Scientistto deliver the following:

* Coordinate and perform the medical analysis of adverse event reports and/or signal detection activities for assigned vaccine projects inclinical 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 theproducts 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 pharmacovigilanceprocesses and related training.
* Answering and follow-up of enquiries from regulatory authorities andother bodies (eg, Ethics Committees) regarding safety-related aspects.
* Implementation of the applicable regulations for the assignedvaccines.
* Participate in IDMC meetings or other safety related interactionswith outside collaborators of the assigned vaccine projects.
* Implementation and follow-up of safety data exchange agreements forproducts assigned.

COMPLEXITY:

* Ability to make independent clinical assessments and decisions, basedon professional and scientific responsibilities to patients, prescribers, regulators, and providers.
* Generating reliable evaluations and recommendations from safety datafrom large and multinational study environment (200,000 subjects forthe ongoing studies)
* Providing scientifically based safety assessments within complexpublic environment.
* Lead cross-functional interactions within the company, such as clinical, regulatory affairs, biostatistics, data management, manufacturing and legal.
* Provide external reference for any safety-related request from local authorities and participate in external meetings with regulatoryagencies or present.

REQUIRED PROFILE:

* Medical Doctor with preferred specialty in Infectious Diseases, Epidemiology or Vaccines
* Minimum 3 years post-registration clinical experience
* 2+ years of experience in the Pharmaceutical or Biotech industryworking 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 (eg International, US and European Legislation).
* Very good understanding of the client' environment and vaccine development process
* Excellent knowledge of safety regulations and working methods.
* Ability to manage crisis, monitor safety issues and work under pressure with a customer and solution oriented approach.
* Able to prioritise activities effectively and to meet multiple deadlines successfully with attention to detail, setting high performance standards for quality
* Demonstrate initiative and creativity in performing task and responsibilities. Proactively contributes ideas to improve existing operations
* Excellent mastery of English, written and spoken with strong communication and influencing skills.
* Integrity and strong feeling for ethics.
* Computer literate, familiar with using scientific and clinical databases.
* Good administrative skills, analytical mind.
* Strong leadership and collaborative working skills

Tags: Manufacturing, pharmaceutical, pharmaceutique, bulk, vaccines,project management