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Job Details

Medical Director- Pharmacovigilance - GI

Company name
Takeda Pharmaceutical Company Limited.

Location
Boston, MA, United States

Employment Type
Full-Time

Industry
Healthcare, Manager, Clinical Research, Research, Sciences

Posted on
Sep 17, 2021

Valid Through
Dec 31, 2021

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Job Description

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

OBJECTIVE: 

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. 

Supporting Therapeutic Lead 

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

ACCOUNTABILITIES: 

Expectation of GSL role for compound(s) both in development  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 ‘own’ compounds with input for other compounds as needed.

Serving in a leadership capacity for complex and strategically important  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:  

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

This job posting excludes CO applicants

TRAVEL REQUIREMENTS:

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

Tuition reimbursement

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

Community Outreach Programs

Empowering Our People to Shine

Learn more at 

takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit 

http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

#LI-MT1

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers.

At Takeda, we do not ask for personal financial information during telephone, in-person or video interviews. And we are investigating ways to mitigate or stop this scheme. If you have concerns related to this issue, consider the following actions: 1) If in the U.S., place a freeze on your credit reports: https://www.consumer.ftc.gov/articles/0497-credit-freeze-faqs;

2) file a complaint with the U.S. Federal Trade Commission: https://www.ftccomplaintassistant.gov/;

and/or 3) file a report with your local police department.

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Company info

Takeda Pharmaceutical Company Limited.
Website : https://www.takeda.com

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