Medical Director

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Medical Director- Pharmacovigilance - GI Company: Takeda Pharmaceuticals International GmbH

Location: Cambridge

Posted on: September 12, 2020

Job Description:

The health and safety of our employees and candidates is veryimportant to us. Due to the current situation related to theCoronavirus (COVID-19), we’re leveraging our digital capabilitiesto ensure we can continue to recruit top talent at Takeda. As yourapplication progresses, you may be asked to use one of our digitaltools to help you through your recruitment journey. If so, one ofour colleagues will explain how these tools will be used during therecruitment process. Thank you.

*Please be aware of an Identity Theft Scheme targetingindividuals seeking jobs with Takeda and other employers. See belowor here for more info.

Medical Director- Pharmacovigilance - GI Takeda fosters acollaborative and stimulating work environment filled withopportunity and the chance to make a difference in people's lives.It is a workplace driven by integrity, one of Takeda’s long-heldvalues that extends to both the patients we serve and our employeeswho develop and deliver medicines. Across our company, Takedaemployees bring together diverse strengths that together create astronger whole.

As one of the world’s leading biopharmaceutical companies,Takeda is committed to bringing Better Health and a Brighter futureto people worldwide. We aspire to bring our leadership intranslating science into life-changing medicines to the next level,in our core focus areas; oncology, gastroenterology, neuroscience,rare diseases, plasma-derived therapies, and vaccines. The GreaterBoston Area is headquarters to many of our Global and US businessunits.

We are a passionate team doing important work that impactspatients’ lives. If you are driven to create better health and abrighter future, join us!

Success What makes a successful member of our team? Check outthe traits we’re looking for and see if you have the right mix.

Life at Takeda A Global Top Employer Recognized for our cultureand way of working, we’re one of only select companies to receiveTop Global Employer ® status for 2020.

Medical Director- Pharmacovigilance - GI Job ID R0021686 Dateposted 08/11/2020 Location Boston, Massachusetts

Are you looking for a patient-focused company that will inspireyou and support your career? If so, be empowered to take charge ofyour future at Takeda. Join us as a PV Medical Director, in ourCambridge, MA office

OBJECTIVE:

Support developmental programs, including both early and latestage development as required.

Responsible for the oversight of signal detection and riskmanagement 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/orscientists

Flexible to support compounds/initiatives outside of primarytherapeutic area(s) as directed by business and departmentalneeds

ACCOUNTABILITIES:

Expectation of GSL role for compound(s) both in development andmarketed in close association with the TAL.

Company wide safety expert for his/her compoundresponsibilities

Intimate knowledge of safety, including any emerging safetyconcerns and risk/benefit profile for ‘own’ compounds with inputfor other compounds as needed.

Serving in a leadership capacity for complex and strategicallyimportant programs

Responsible for development of documents and for negotiationwith Regulatory authorities on safety matters involving thesecompounds. This includes but is not limited to: direct interactionwith Regulatory authorities, authorship of safety summaries tosupport changes to the PI/SmPC, significant contribution to MAAsand NDAs, authorship of Executive Summaries on special safetytopics, authorship of Integrated Analyses of Safety (IAS) for CTDsetc

Training and mentoring of Pharmacovigilance Physicians andSpecialists

Perform activities required to serve as Global PV physician:

Review and oversight of safety data, both non-clinical andclinical

Review and/or sign off of protocols, SAPs, clinical studyreports, IBs, IMPD and other documents developed for submission toregulatory authorities

Interactions with external experts and regulatory agencies andpartner/co-development companies

Review of safety data and participate in dose escalationdecisions

Authorship and sign off of Safety Monitoring Plan/RiskManagement Plan

Lead data analysis and writing of regulatory submissiondocuments, for license application and variation activities and forsafety issues and questions from regulators

Direct the set up of safety procedures and development of safetyexchange agreements for co-development projects

Maintain professional knowledge and accreditation by activeparticipation in continuing medical education activities

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Knowledge of principles of epidemiology and statistics.

Critical thinking and analytical skills and ability to make highlevel decisions

Excellent oral and written communication skills includingability to present to large internal/external groups

Good level of computer literacy with Microsoft applications

Minimum of 8 years experience in pharmacovigilance, clinicalresearch or clinical development

2-3 years clinical experience with patients followingpost-graduate training with significant knowledge of generalmedicine

TRAVEL REQUIREMENTS:

Estimated up to 5 travel times per year, including possibleinternational travel.

WHAT TAKEDA CAN OFFER YOU:

401(k) with company match and Annual Retirement ContributionPlan

Company match of charitable contributions

Health & Wellness programs including onsite flu shots and healthscreenings

Generous time off for vacation and the option to purchaseadditional vacation days

Check out where you could be

working if you apply.

Job Seekers: Protect yourself against identity theft Please beaware there are instances of identity thieves postingTakeda-branded jobs and posing as employees to steal personalinformation. They visit job-related websites and invite candidatesto online chats. During the chat, they press job seekers to providebank account information and Social Security numbers.

Copyright 1995-2019 Takeda Pharmaceutical Company Limited. Allrights reserved.

Keywords: Takeda Pharmaceuticals International GmbH, Cambridge , Medical Director- Pharmacovigilance - GI, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Medical Director, Other , Cambridge, Massachusetts