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Drug Safety Physician
3 months ago
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics.
PURPOSE OF THE ROLE
- To perform the medical assessment of individual case safety reports (ICSR) in safety database system. Work in close collaboration with the involved stakeholder to ensure that each case is assessed in a proper way to ensure patients safety.
- Work with the vendor performing the case management and/or medical assessment of ICSR to ensure the medical quality of the ICSR.
- Interface with medical safety teams on active pharmacovigilance activities on products in clinical development and postmarketing.
KEY TASKS & RESPONSIBILITIES
(In order of importance and time spent; should include 80% of responsibilities)
- Medical review and approval of ICSR clinical trial cases by performing a thorough medical evaluation of serious and nonserious cases, authoring and/or reviewing the PV comment
- Contribution to quality KPI compilation while assessing the quality of medical assessment of cases reviewed and approved by vendors
- Ensure timely completion of the task by daily monitoring of workflows
- Ensure close interaction with Medical Safety if an "Indexcase" was identified
- Ensure issuing of proper medical queries to obtain followup information for the ICSR
- Provide operational expertise in case processing activities
- Contribute to regulatory inspections and audits and support the development of CAPA plans as needed
- Maintenance & data cleaning of reference tools and documents relevant to medical review activities
- Participate in internal and external training programs, meetings, and conferences to continually improve and build a knowledge base of product safety and risk management.
EDUCATION & LANGUAGES
- Physician with MBBS/MD degree including relevant clinical experience
PROFESSIONAL SKILLS & EXPERIENCE
- Minimum 3 years of professional experience/experience in the pharmaceutical or biotech industry with at least 2 years in patient safety/pharmacovigilance
- Minimum of 2 years working in hospital or private praxis prior to joining the pharmaceutical industry
- Expert knowledge of international regulatory safety reporting requirements, including EMA/FDA/ICH guidance's related to pharmacovigilance (e.g. E2B) and Good Pharmacovigilance Practices, as well as working knowledge of Code of Federal Regulations regarding drug safety
- Expert in Medical Coding (e.g. MedDRA)
- Good understanding of drug development and lifecycle management
PERSONAL SKILLS & COMPETENCIES
- Ability to work in intense, fast paced, matrixed, multinational work environment
- Strong communication skills (oral, written and listening)
- Ability to effectively communicate with employees, colleagues, and global counterparts
- Positive motivator through demonstration
- Strong intercultural skills (developed from practical experience)
- Strong teamworking skills working across cultural and functional boundaries, and participating 'virtual teams'
- Good problemsolving and decisionmaking ability
- Good organizational skills, ability to prioritize work and adapt rapidly to changing priorities
- Ability to manage multiple situations/issues under time pressure
- Effective presentation and training skills
- Ability to present and critically discuss safety data in both internal and external discussions
- Ability to evaluate, interpret and synthesize scientific data (analytical thinking)
- Team player with ability to function in a crossfunctional environment
- Selfmotivated, able to prioritize and plan effectively, and independently, with mínimal supervision
- Ability to navigate in databases and pull information correctly
- Good organizational skills and attention to detail
What we offer:
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology.
We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress