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 Director Medical Review Pharmacovigilance in our Cambridge, MA office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director Medical Review working on the PV Services team, you will be empowered to Create and Strategize. A typical day will include:
The Director, Global Medical Review supports Global Pharmacovigilance with an emphasis on overseeing medical assessment of individual case safety reports from investigational and marketed product across all therapeutic areas.
Responsible for overseeing high quality medical assessment of individual case safety reports in the Global Safety Database to ensure compliance with domestic and international regulations.
This position leads and manages all aspects of global medical review and provide medical oversight to the Case Management Team and also for outsourced medical review activities.
Also provide guidance and leadership in harmonization of medical assessment of LOCs originated cases.
Ensures that all medical reviewers are adequately trained to perform medical review of the ICSRs in the Global Safety Database as per company SOPs and guidelines.
Oversight of global medical review of individual case safety reports for Takeda investigational and marketed products from all sources includes but not limited to the following:
seriousness criteria confirmation and expectedness/listedness assessment
review of the reporter’s causality and company causality assessment
event confirmation and coding as per convention,
analysis of similar events as required
case narratives for data accuracy and completeness; and
ensure due diligence in adequate follow-up
accuracy of the data and timeliness of expedited reports
Collaborate with the Head of Global Case Management to establish a Center of Excellence for narratives for both clinical study and post-marketing case reports
Oversight of medical input from medical monitors and safety leads as well as from other stakeholders for ad-hoc queries for ICSRs
As a subject matter expert, provides oversight of all aspects of outsourced medical review activities including required training for the medical reviewers. This includes but is not limited to provide guidance in terms of overall case assessment on real time; clarification of medical review related issues with prompt resolution etc.
Establish with alliance partners harmonization and industry standard medical review and case assessment standards
Ensure effective communication with both internal and external stakeholders on individual case safety assessment related issues and prompt response to the queries
Keep management informed of special concerns and developing safety problems with investigational compounds and marketed products
Work closely with LOCs/DSOs; PV Case Management and Operations and interface with CRO Safety
Review safety sections of clinical trial protocols, investigator brochures, and informed consents for selected drug development programs. Perform such other duties as requested by management
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Medical degree required or internationally recognized equivalent
Substantial pharmaceutical or health care related industry experience required
High level of experience in Pharmacovigilance including medical review of individual case safety reports
Moderate clinical experience with patients following post-graduate training with significant knowledge of general medicine
Experience managing physicians with ability to empower, develop and motivate staff
Excellent oral and written communication skills including ability to present to large internal/external groups
Multi-tasking with the ability to successfully manage multiple critical issues simultaneously
Work productively in a high pressure environment
Good analytical/judgment/ critical thinking capabilities to understand/analyze/synthesize and communicate
Project Management abilities
Strong knowledge of business area and interactions with strong regulatory environment and ability to identify and understand proactively the interactions necessary for achieving business goals and objectives
Able to manage both time and priority constraints and to manage multiple priorities simultaneously
Attention to details, computer literacy, knowledge of safety database
Take initiative and autonomous action
Able to lead teleconferences and meetings
Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / coaching skills
Some travel to global Takeda sites may be required.
ADDITIONAL US SPECIFIC INFORMATION (FOR US RECRUITMENT ONLY):
Minimum 10 years pharmaceutical or health care related industry experience required
Minimum of 5 years experience in Pharmacovigilance including medical review of individual case safety reports
2-3 years clinical experience with patients following post-graduate training with significant knowledge of general medicine
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