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 Safety Analytics and Reporting Lead (Senior Prof) in our Cambridge, MA office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As Safety Analytics and Reporting Lead, you will be empowered to Innovate and Strategize.
- Provides safety expertise, including support for regulatory submissions and responses, aggregate reports, white papers, etc.
- Expert from safety science perspective in primary therapeutic area
- Potential Global Safety Lead for one compound
- Flexible outside of primary therapeutic area(s) as directed by business and departmental need
- Serve as the Lead PV Scientist
- Responsible for reviewing, analyzing, and interpreting information from ongoing clinical and non-clinical studies alongside the assessment of ensuing scientific and medical implications of making recommendations based on new safety information for both developmental compounds and marketed drugs to ensure the primacy of patient safety
- PV science expert for designated compound(s) within primary therapeutic as appropriate oversees safety and process activities within these therapeutic areas.
- Integral to GST and GCDT and assisting with writing/reviewing of aggregate reports including the RMP.
- Direct, mentor, and develop PV Science colleagues commensurate with his/her experience.
- Ability to functions as senior contact for safety related matters to cross functional groups and external bodies.
- Maintains compound and more general safety expertise
- Provides strategic and technical expertise and leadership. Sets medical, scientific and process standards for all products within these therapeutic areas.
- Contributes to clinical program and protocol design, safety risk management, signal detection.
- Oversees PV reports and submissions in designated therapeutic area(s), e.g., aggregate reports and regulatory submissions.
- In collaboration with the PV TA Lead, leads evaluation and management of emergent safety issues.
- Ensures adequate internal support and external resourcing (CRO & BPO) to deliver all safety reports.
- Ensures adequate distribution of assignments and prioritization of tasks within the PV specialist s staff.
- Interfaces with functional areas within and outside PV.
- Minimum 3 years experience in Pharmacovigilance with significant experience in preparing regulatory documents.
- Bachelor s degree required. Advanced degree or specific pharmacovigilance qualification preferred (MD, PhD, and PharmD).
- Comprehensive understanding of PV process in aggregate submissions and the new regulations that have been established.
- Expert knowledge of clinical trial and pharmacovigilance methodologies including safety profile and risk/benefit analysis and detailed comprehension of global regulatory requirements
- Excellent organization skills and ability to prioritize individual and team work loads.
- Excellent written and oral communication skills including ability to present to large internal/external groups
- Capability to synthesize and analyze data from multiple sources.
- Expertise in pre and post marketing SD.
- Demonstrated leadership skills with proven ability to motivate and work in multidisciplinary teams.
- Experience in the support of post marketing surveillance and reporting to Regulatory Authorities worldwide.
- Strong understanding of the clinical development and regulatory process.
- Practical experience in the interpretation of global Pharmacovigilance regulations and implementation within an industry setting.
- Competence in conducting safety data reviews for investigational and/or post marketed products.
- High level of expertise and experience in the preparation of aggregate safety reports, including ICH-compliant PBRERs and responses to ad hoc regulatory queries; significant experience in the mentoring, training and assessment of staff involved in the preparation of aggregate safety reports.
- Experience with MedDRA and drug coding reviews.
- Ability to contribute to and review standard operating procedures and other process-related documents.
- Excellent communication, collaboration and networking skills.
- Strong understanding of the interface between Pharmacovigilance and external departments.
- Ability to influence others within a matrix environment.
- Must be able to work in a fast paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands.
- Ability to work independently, take initiative and complete tasks to deadlines.
- Forward-planning and proactive.
Some travel to global Takeda sites may be required.
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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.
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