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: Global Safety Lead (Associate Medical Director)
POSITION DESCRIPTION: Baxalta US Inc., a Takeda Company, is seeking a Global Safety Lead (Associate Medical Director) with the following duties: act as drug safety expert for assigned products; maintain current knowledge of safety profiles for assigned products; oversee safety surveillance, risk management, and risk communication for assigned development and marketed products as well as medical assessment of individual adverse event reports, generation, and review of aggregate reports and safety documents, including product labeling changes; provide drug safety support for internal and external customer; review all safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout development process as well as post marketing; manage overall safety signal detection, monitoring, evaluation, interpretation and appropriate management of safety information; lead Safety Review Teams responsible for management of ongoing and cross functional assessment of benefit risk profiles and related actions; provide key content for Risk Management documents including risk management plans (RMPs), risk evaluation and mitigation strategies (REMS); provide input in and support generation of periodic reports for assigned products; provide medical interpretation, review and approval for required reports; share drug Safety and medical expertise with global counterparts in other functional areas including Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal; update safety information in Company Core Data Sheet and Investigator Brochure as well as other labeling documents; ensure accurate representation and communicate of the safety profile of assigned drugs or biologics in collaboration with Regulatory Affairs labeling team; respond to inquiries from regulatory authorities on safety issues; provide integrated safety input into all regulatory documents where required; perform thorough assessment of safety profiles for Due Diligence project; provide Drug Safety input for product recall issues or Health Hazard Evaluations and Dear Healthcare Professional letters; perform Medical Review of all adverse event reports for seriousness, expectedness and causality; assist Scientists with medical opinion on obtaining follow-up information for individual cases; participate in review of scientific literature: identify case reports that meet criteria for entry into the safety database; identify relevant safety articles/references involving the active ingredients of marketed products and products in development; create literature summary sections to be included in periodic safety update reports (PSURs) and other required reports; represent Global Drug Safety in leadership committees and activities both internally and externally when appropriate; ensure communication of all Global Pharmacovigilance and drug/biologic safety issues to Senior Pharmacovigilance Management; conduct medical review in validated database systems including Argus and ArisG; author and review aggregate safety reports (PSUR and DSUR) for global submission, of products in therapeutic areas including hematology, oncology, and immunology; provide medical safety input to clinical teams in developing clinical trial protocols and conduct of clinical trials; provide safety oversight for products in oncology, hematology, and immunology therapeutic areas.
REQUIREMENTS: Doctor of Medicine or MD plus 1 year related experience. Will accept any level of experience in the following required skills: conduct medical review in validated database systems including Argus and ArisG; author and review aggregate safety reports (PSUR and DSUR) for global submission, of products in therapeutic areas including hematology, oncology, and immunology; provide medical safety input to clinical teams in developing clinical trial protocols and conduct of clinical trials; provide safety oversight for products in oncology, hematology, and immunology therapeutic areas.
Full time. $179,000.00 - $200,000.00/year. Competitive compensation and benefits.
Qualified applicants can apply directly to the Baxalta Website at: www.Baxalta.com. Please reference job #R0029620. 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/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
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.