Description
One of our clients, an international company in the pharmaceutical industry currently requires a Safety Physician with min. 2 years' experience in the pharmaceutical industry
Start: ASAP
Lenght: 6 months
Location: South of Brussels
Safety Physician
JOB PURPOSE:
To actively manage and evaluate risks associated with assigned vaccine projects, and make recommendations for the management and communicationof 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 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 (eg, 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.
COMPLEXITY:
* Ability to make independent clinical assessments and decisions, based on professional and scientific responsibilities to patients, prescribers, regulators, and providers.
* Generating reliable evaluations and recommendations from safety data from large and multinational study environment (200,000 subjects for the ongoing studies)
* Providing scientifically based safety assessments within complex public environment.
* Lead cross-functional interactions within the company, such asclinical, 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 regulatory agencies 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 industry working in Clinical Development, Medical Affairs, Pharmacovigilance, Drug Safety or a related field.
* Knowledge of Pharmacovigilance and signal detection tools, analysisand reporting of medical safety issues for vaccines, taking into account the worldwide regulatory requirements.
* Knowledge and experience in collection and interpretation of SeriousAdverse Events case reports.
* In depth understanding of the regulatory environment (egInternational, US and European Legislation).
* Very good understanding of the vaccine development process
* Excellent knowledge of safety regulations and working methods.
* Ability to manage crisis, monitor safety issues and work underpressure with a customer and solution oriented approach.
* Able to prioritize 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 andresponsibilities. 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: Physician, Safety, clinical, vaccines, risk, pharmaceutical