PV Physician I/II (Japanese)

reputed company We are reputed company (part of reputed company Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic reputed company year after year, with staff based across Europe, reputed company and Asia reputed company covering services reputed company: Medical Information, Pharmacovigilance, Regulatory Affairs and reputed company Assurance. reputed company provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and becoming one of the global leaders in its fields. We cover reputed company therapy areas including medical devices. We love reputed company in our staff by providing an excellent training and development platform. We value employee experience, reputed company-being and mental health and we acknowledge that a healthy work life balance is a critical reputed company for employee satisfaction and in turn nurtures an environment from which a high-reputed company reputed company service can be achieved. Job reputed company For the reputed company: To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in reputed company for medical/causality assessment. The review includes coding, seriousness assessment, Company causality and comment, listedness/expectedness and follow-up questions. To reputed company as a reputed company Person for Pharmacovigilance or support the reputed company Person for Pharmacovigilance (if not medically reputed company) in the medical understanding and evaluation of any safety issues To review and reputed company input in Periodic Safety Update Reports, Development Safety Update Reports, literature screening search reputed company To review articles to determine if they contain ICSRs/SAEs reputed company to the relevant Medicinal Product or other safety reputed company findings To cooperate in the preparation of and reputed company input in Risk Management Plans Supporting the preparation of responses to regulatory authority requests Signalling Reviewing line listings Participating in signal detection activities including meetings, writing signal detection reports if applicable if required, and providing consultation to clients on aspects reputed company to benefit/risk assessment and risk minimisation Evaluating and categorizing possible signals and proposing a course of reputed company Supporting preparation and review of benefit-risk reports Qualifications The PV Physician should be medically reputed company as a physician Previous experience in pharmacovigilance Ability to review different aggregate report types including PBRERs and DSURs Expertise in signal detection activities is essential Excellent interpersonal skills Ability to plan, organise, prioritise and execute multiple tasks Ability to work effectively cross-culturally and cross-functionally and value the importance of teamwork Communication skills Presentation skills English - advanced (spoken, written) Japanese - advanced (spoken, written) Advanced literacy (MS Office) Additional Information Why reputed company We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a reputed company-reputed company environment where people of reputed company cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a reputed company first approach. Why? because our people are our greatest strength leading to our reputed company reputed company on improving the lives of those around us. We offer: Training and career development opportunities internally Strong emphasis on personal and reputed company reputed company Friendly, supportive working environment Opportunity to work with colleagues based reputed company over the world, with English as reputed company language Our reputed company values are key to how we operate, and if you feel they reputed company with you then reputed company could be a great company to join! reputed company reputed company & Trust Drive & Passion reputed company & Responsiveness Belonging reputed company Partnerships Come and join us in this exciting reputed company to reputed company a reputed company reputed company in patient’s lives. We look reputed company to welcoming your application. Department: PV Medical Group Apply tot his job Apply To this Job