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Safety Study Lead

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

Job Description:

Company: Shire plc

Location: Cambridge

Posted on: September 12, 2020

Job Description:

United States - Kendall Square Cambridge MA

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 Safety Study Lead in ourCambridge, MA office.

OBJECTIVES/PURPOSE

The Post Marketing Safety Study Lead is responsible for theoversight of Post-marketing safety studies including EUPost-authorization safety studies (PASS), Regional Post-marketingsurveillance studies and other activities to ensure compliance withPost-marketing safety regulations, requirements, commitments andmilestones in Risk Management Plans.

ACCOUNTABILITIES

Accountable for the global tracking of ongoing and plannedpost-marketing safety studies, including PASS, Post-marketingcommitments, Post-marketing requirements and other post-marketingactivities.

Accountable for monitoring study progress, updating aggregatereports and providing updates to the Safety Management Team asneeded.

Collaborates closely with the Local Country offices, includingMedical affairs, Drug Safety, and Regulatory Affairs in support ofRegional post-marketing surveillance studies, Pharmacovigilanceprograms and other activities undertaken as part of RMPcommitments.

Collaborates closely with Global evidence and outcomes andGlobal Medical affairs in support of post-authorization studies,including Registries

Coordinates and contributes to the development of Post-marketingsafety study protocols, study reports and other relateddocuments/commitments

Liaises effectively with local country offices and localaffiliates in the understanding of local and country regulationswhich affects post-marketing commitments

Represents PMS study team on cross functional teams andinterfaces with other functional groups such as Regulatory Affairs,Clinical Development, Clinical Operations, Medical Affairs,Compliance, as needed.

Ensures that study timeline risks with post-marketing safetystudy projects are identified promptly, and mitigation plans areput into place.

Contributes to on-going process enhancement for post-marketingsafety studies and other post-marketing activities

Contributes to Health Authority inspection and audit support forpost-marketing safety studies

Participates in other activities, teams and committees asassigned

DIMENSIONS AND ASPECTS

Ability to improvise and demonstrate creativity in solvingproblems and achieving objectives

Proficiency with electronic search engines of the medicalliterature

Ability to read and analyze scientific and medicalliterature

Ability to work with interdisciplinary, highly matrixed team

Knowledge of global regulations and guidance related to Postmarketing studies Pharmacovigilance, risk management

Requires strong attention to detail in composing andproof-reading materials, establishing priorities, scheduling andmeeting deadlines

Excellent written, oral communication and presentationskills

Must be able to work in a fast-paced environment withdemonstrated ability to simultaneously manage multiple competingtasks and demands

Ability to work independently, take initiative and completetasks to deadlines

Working knowledge of MedDRA terminology and practices

Good working knowledge of MS Word, Excel, PowerPoint andOutlook.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

PharmD or Master’s degree in a science or healthcare relateddiscipline

Generally, has 3+ years of experience in conductingPost-approval safety studies or other studies in the pharmaceuticalindustry or CRO.

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

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 withcriminal histories in accordance with applicable laws. For moreinformation, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

#LI-MT1

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates forvacancies only if they have written authorization to do so fromShire, a wholly-owned subsidiary of Takeda’s Talent Acquisitiondepartment. Any agency candidate submission may only be submittedto positions opened to the agency through the specific AgencyPortal. Shire, a wholly-owned subsidiary of Takeda will only pay afee for candidates submitted or presented where there is a fullyexecuted contract in place between the Employment / Recruitmentagents and Shire, a wholly-owned subsidiary of Takeda and only ifthe candidate is submitted via the Agency Portal. Candidatessubmitted or presented by Employment / Recruitment Agents without afully executed contract or submitted through this site shall not bedeemed to form part of any Engagement for which the Agency mayclaim remuneration.

Equal Employment OpportunityShire, a wholly-owned subsidiary ofTakeda, is an Equal Opportunity Employer committed to a diverseworkforce. Shire, a wholly-owned subsidiary of Takeda, will notdiscriminate against any worker or job applicant on the basis ofrace, color, religion, gender, national origin, ancestry, age,sexual orientation, marital or civil partnership status, pregnancy,gender reassignment, non-job related mental or physical disability,genetic information, veteran status, military service, applicationfor military service, or membership in any other category protectedunder law.EEO is the Law -https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdfEEO is the Law – Supplement -https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdfPay Transparency Policy -https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdfReasonable AccommodationsShire, a wholly-owned subsidiary ofTakeda, is committed to working with and providing reasonableaccommodation to individuals with disabilities. If, because of amedical condition or disability, you need a reasonableaccommodation for any part of the application process, or in orderto perform the essential functions of a position, please call484-595-8400 and let us know the nature of your request and yourcontact information.

Posted 2 Days Ago

Full time

R0049326

About Us Takeda is an industry-leading, global pharmaceuticalcompany with an unwavering dedication to putting patients at thecenter of everything we do. We live our values of Takeda-ism –Integrity, Fairness, Honesty, and Perseverance – and are united byour mission to strive towards Better Health and a Brighter Futurefor people worldwide through leading innovation in medicine. Here,everyone matters and you will be a vital contributor to ourinspiring, bold mission. At Takeda, you will make an impact onpeople’s lives – including your own.

Keywords: Shire plc, Cambridge , Safety Study Lead - Post Marketing, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Safety Study Lead, Other , Cambridge, Massachusetts

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