Shire Associate Director, Safety Analytics and Reporting Lead in Cambridge, Massachusetts

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification has been filed by Baxalta US Inc., a Takeda Company for the following job opportunity:

JOB LOCATION: Cambridge, MA

POSITION: Associate Director, Safety Analytics and Reporting Lead

POSITION DESCRIPTION: Baxalta US Inc., a Takeda Company, is seeking a Associate Director, Safety Analytics and Reporting Lead with the following duties: manage aggregate and ad-hoc safety report production; maintain oversight of signal detection methodologies and tracking tools to support Takeda’s signal management process; active involvement in Safety Governance structure to ensure quality standards are being followed and support benefit-risk assessment of Takeda products throughout entire lifecycle; responsible for oversight of relationship between drug safety and vendor(s) to support surveillance activities; support implementation of established standards and compliance strategies for the drug safety team; support post marketing surveillance utilizing practical experience with ARGUS safety database and reporting to Regulatory Authorities worldwide; utilize knowledge of clinical development and regulatory process; interpret global Pharmacovigilance regulations and implement within an industry setting; perform MedDRA and WHO-DD coding reviews; mentor, train and assess staff involved in preparation of aggregate safety reports.

REQUIREMENTS: Master’s degree in Chemistry or related field plus 5 years related experience OR Bachelor’s degree in Chemistry or related field plus 7 years related experience. Will accept any level of experience in the following required skills: support post marketing surveillance utilizing practical experience with ARGUS safety database and reporting to Regulatory Authorities worldwide; utilize knowledge of clinical development and regulatory process; interpret global Pharmacovigilance regulations and implement within an industry setting; perform MedDRA and WHO-DD coding reviews; mentor, train and assess staff involved in preparation of aggregate safety reports.

Full time. $179,000.00- $185,000.00/year. Competitive compensation and benefits.

Qualified applicants can apply directly to the Baxalta Website at: www.Takeda.com. Please reference job #R0029927. EOE

Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Foreign Labor Certification National Processing Center, Harris Tower, 233 Peachtree Street, Suite 410, Atlanta, GA 30303.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, 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, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.