Medical Director/Sr. Medical Director US Patient Safety Surveillance
San Mateo , California
October 17, 2017
Medical Director US Patient Safety Surveillance
About AstraZeneca
As one of the world's leading pharmaceutical companies, our business is focused on providing innovative, effective medicines that make a real difference in important areas of healthcare. At AstraZeneca, innovation is about more than just research. We aim to stimulate continued creativity throughout our organization by maintaining a culture in which our people feel valued, energized and rewarded for their ideas and contribution to our success - ideas which can make a difference in all aspects of our business. And we support and encourage our people in discovering their own potential, through excellent learning and development opportunities that are available to them throughout their careers.
Major Duties and Responsibilities
The role holder promotes the safety of patients who receive AstraZeneca products, with the aim of optimizing overall benefit/risk with a focus on the Renal Cardio Therapeutic Area (RCTA) in the US market.  The role holder is accountable to the US Head of Patient Safety Suveillance for patient safety surveillance activities on RCTA sponsored clinical studies, US post-marketing safety evaluations, as well as contributing to Global benefit risk assessment, risk management strategies and related activities.   The role holder will also be accountable for deliverables of patient safety support to the US Medical Affairs and RCTA brand team, including US products' benefit risk assessment, management, mitigation, training, and communications.  The role holder also collaborates with US and Global Patient Safety, Medical Affairs, Regulatory Affairs, R&D, and Legal functions. 
  • Accountable for US patient safety surveillance activities for RCTA
  • Leads cross-functional and multi-skilled safety surveillance team in RCTA to ensure delivery of US PS surveillance activities
  • Safety contributions to US MA clinical research activities for the RCTA
  • As core member of Risk Evaluation and Mitigation teams to be accountable for providing safety input to US REMS activities
  • Provides US Patient Safety expertise in the development of strategy for FDA regulatory response documents
  • Oversees or provides expert technical support to AstraZeneca clients on a regional and potentially global basis
  •  Safety input into US Issues Management
  • Provides US PS input to product global safety governance teams (i.e., SSaMTs)
  • Contributes to the content of the Safety Sections of the US Prescribing information
  • Represents AstraZeneca and US Patient Safety at external events
  • Networks with colleagues and experts, providing consultancy in own area of expertise and serving as a resource for others by sharing experience within and beyond project team and function
  • Keeps own knowledge of best practices and new relevant developments up to date
  • Litigation safety support
  • Closely collaborate with other relevant stakeholders in the global and US business (including regulatory, medical affairs, evidence generation, legal)
  • Safety and medical input into brand strategy as a member of RCTA Core Medical Team (CMT)
  • Supply medical input into safety profile of the product in collaboration with other Medical Affairs physicians
  • Provide safety / medical training for external medical/scientific speakers
  • Provide safety clinical education and safety / medical training for internal stakeholders such as MSLs, sales, and brand teams
  • Provide safety / medical input and review of the Brand Team Externally Sponsored Research (ESR) program and Publication Strategies
  • Interact with external scientific leaders in the therapy area from both safety and medical point of view
  • Work with commercial brand teams to provide safety scientific and clinical expertise/input into strategic and tactical decisions in support of AstraZeneca products acting as medical expert for disease area
  • Work closely with our Field Medical Teams to appropriately support customer needs
  • Supply safety / medical insight into promotional material for internal and external use
  • Actively contribute safety / medical and scientific input to relevant internal Brand, and Managed Markets teams regarding product strategy
  • Actively contribute to safety / medical input for global clinical activities with global TA physicians including global brand strategy, clinical trials, brand safety profile, and brand payer dossiers
  • As a Safety / Medical expert, supply medical input into global Phase III programs and/or Life Cycle Management (LCM) programsEssential Requirements
  • MD or equivalent degree from US or reputable foreign medical university
  • At least 2 years of clinical experience post-registration/certification
  • Two or more years of pharmacovigilance and/or drug development experience obtained while working in the pharmaceutical industry or academia
  • High level of medical competence, with an ability to balance this with industry standards to achieve business goalsDesirable Requirements
  • 3 years clinical practice experience
  • Medical residency training or equivalent experience
  • At least 5 years of drug development and/or pharmacovigilance experience (the majority of which should be in pharmacovigilance) with clear evidence of delivery
  • Extensive general medical knowledge
  • Postgraduate training with board certification or equivalent
  • Extensive safety experience in the pharmaceutical industry
  • Experience working in Medical Affairs roles in the pharmaceutical industry
  • Working knowledge of epidemiology
Next Steps - Apply Today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer.  AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

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