Add to Calendar2019-09-20 08:00:002019-09-21 11:15:00Emerging Topic Conference: The Genomics Revolution
The conference will focus on genomics and the changing approach to diagnostics, management and research in adult and pediatric liver diseases.
Arlington, VA 22202
Add to Calendar2019-10-04 08:00:002019-10-05 14:00:00AASLD / EASL ALD Conference
This meeting will bridge critical gaps in ALD diagnosis, management and clinical trial design.
1 W. Wacker Drive
Chicago, IL 60601
Add to Calendar2019-11-08 09:00:002019-11-12 14:00:00The Liver Meeting
The Liver MeetingÂ® is the annual must-attend event bringing together 9,500 attendees from around the world to exchange the latest research, discuss new developments in treatment outcomes, and network with other experts in the field.
Add to Calendar2019-12-14 08:00:002019-12-15 17:00:00TASL-AASLD Joint Symposium: HBV Elimination
Doctors Anna S. Lok and K. Rajender Reddy will join Dr. Jia-Horng Kao and other faculty from Taiwan to host the first TASL-AASLD Joint Symposium as part of the TASL (Taiwan Association for the Study of the Liver) Annual Meeting, December 14-15, 2019 in Taipei.
Beitou District, Taipei City
Add to Calendar2020-03-20 08:00:002020-03-21 15:00:00Emerging Topic Conference: Nuclear Receptors as Common Clinical Targets for the Treatment of Cholestatic and Nonalcoholic Fatty Liver Diseases
More information is coming soon.
LiverLearningÂ® is the official eLearning portal of AASLD. Users can access educational resources by topic, speaker, event, and content type â€” including video, audio, and slide decks. Continuing education (CME/CE credits and MOC points) is available for a variety of enduring materials on the portal. All current AASLD members automatically receive complete access to LiverLearningÂ®, and non-members can purchase access for one year with a subscription.
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a PV Medical Director, in our Cambridge, MA office
Support developmental programs, including both early and late stage development as required.
Responsible for the oversight of signal detection and risk management activities for designated global/regional product(s), together with global safety lead responsibly as appropriate.Â
Supporting Therapeutic LeadÂ
Line management responsibilities for junior physicians and/or scientists
Flexible to support compounds/initiatives outside of primary therapeutic area(s) as directed by business and departmental needs
Expectation of GSL role for compound(s) both in developmentÂ and marketed in close association with the TAL.
Company wide safety expert for his/her compound responsibilities
Intimate knowledge of safety, including any emerging safety concerns and risk/benefit profile for âownâ compounds with input for other compounds as needed.
Serving in a leadership capacity for complex and strategically importantÂ programs
Responsible for development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes but is not limited to: direct interaction with Regulatory authorities, authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs etc
Training and mentoring of Pharmacovigilance Physicians and Specialists
Perform activities required to serve as Global PV physician:
Review and oversight of safety data, both non-clinical and clinical
Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities
Interactions with external experts and regulatory agencies and partner/co-development companies
Review of safety data and participate in dose escalation decisions
Authorship and sign off of Safety Monitoring Plan/Risk Management Plan
Lead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators
Direct the set up of safety procedures and development of safety exchange agreements for co-development projects
Maintain professional knowledge and accreditation by active participation in continuing medical education activities
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Â
Qualified physician (Licence, e.g. GMC registered, preferred)
Knowledge of principles of epidemiology and statistics.
Critical thinking and analytical skills and ability to make high level decisions
Excellent oral and written communication skills including ability to present to large internal/external groups
Good level of computer literacy with Microsoft applications
Minimum of 8 years experience in pharmacovigilance, clinical research or clinical development
2-3 years clinical experience with patients following post-graduate training with significant knowledge of general medicine
Estimated up to 5 travel times per year, including possible international travel.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.