Posted to MedZilla on 10/16/2018


Takeda Pharmaceuticals

US-MA, Lead PV Scientist R0004899-MZ


 
 

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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 Lead PV Scientist in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission.

OBJECTIVE:

Provides pharmacovigilance functional area expertise and support to project teams for assigned developmental and/or marketed products in conjunction with pharmacovigilance physicians * Responsible for operational pharmacovigilance activities for assigned developmental and/or marketed products * Represent pharmacovigilance department internally and externally at a global level and to function as an authoritative and professional member of relevant teams. * Lead signal detection/safety monitoring activities for pharmacovigilance operations. * Provide functional & therapeutic area expertise, thereby supporting junior pharmacovigilance scientist * Flexible outside of primary therapeutic area as directed by business and departmental need

ACCOUNTABILITIES:

Technically fully competent to perform all usual Senior Pharmacovigilance Scientist workload, including case report QC, review, follow-up and reportability assessments and input into aggregate safety reports * Liaise with other relevant functional areas both within and outside of global PV * Represent pharmacovigilance department in cross-functional teams or committees and external environments at a global and regional level as required. * In depth knowledge and understanding of designated products/studies. * Provide support and oversight of pharmacovigilance operational activities within therapeutic area * Mentorship and guidance for junior/new pharmacovigilance scientists * Conduct project activities for designated developmental products: * Lead set up of safety procedures for complex developmental programmes o Contribute to development of safety exchange agreements for co-development projects

o Review and provide functional area expertise for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents o Close knowledge of protocols to effectively respond to safety issues. o Providing investigator and monitor training on safety procedures o Participate in Global Safety Teams, coordinating all aspects of signal detection/safety review activities. o Draft responses to regulatory/ethics safety questions o Assist with writing and maintenance of the Safety Monitoring Plan o Assist with set-up and running of DSMBs o Close working relationship with physicians, both technically and managerially o Perform ad hoc analyses e.g. in response to regulatory queries o Integral to Global Safety Teams and associated support o Other functions as directed by departmental and business needs * Any other tasks assigned by manager to assist in departmental activities

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Health care background or life science degree level qualification/Bachelors required; Advanced degree in scientific/medical field preferred * Excellent databases and coding skills including ability to perform advanced searches * In depth knowledge of clinical trial methodology, pharmacovigilance regulations, safety profile and risk/benefit analysis. * Critical thinking and decision making skills * Ability to review, analyse, interpret and present complex data to a high standard * Global player in a global PV organistion * Excellent communication and presentational skills * Good level of computer literacy * Excellent organisation skills and ability to prioritise

TRAVEL REQUIREMENTS:

* Estimated 5-10 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.

No Phone Calls or Recruiters Please.

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