Head of Safety Surveillance Research

ROLE SUMMARY

The successful candidate will lead the design, implementation and execution of pharmaco-epidemiological approaches that will support and inform the safety signal identification, investigation, confirmation or rejection from both classical and novel global data sources, for investigational and marketed products. By understanding the frequency of certain symptoms, concurrent illnesses, co-medications or alternative therapeutic approaches, the data generated by Safety Surveillance Research will contextualize any emerging or established safety signal. The successful candidate will also lead the design, implementation and execution of the Post-Approval safety Studies (PASS) in order for Pfizer to comply with its global commitments to evaluate the potential risk of approved medicines, and assess the effectiveness of risk-management and mitigation interventions.

ROLE RESPONSIBILITIES

Strategic Thinking:

• Leads a team of Safety Surveillance Research Scientists accountable for the design, planning, implementation and execution of pharmaco-epidemiological approaches to evaluate the safety of medicines, vaccines biologics and devices across the development process and lifecycle continuum for the entire Pfizer portfolio.
• Safety Surveillance Research Scientists, under the leadership of the Head Safety Surveillance Research, will also be responsible the design, implementation and execution of the Post-Approval safety Studies (PASS), ensure PASS are tracked, and appropriately categorized in the clinical trial repository in order for Pfizer to comply with its global commitments to evaluate the potential risk of approved medicines, and assess the effectiveness of risk-management and mitigation interventions. To develop these PASS studies they will work in close collaboration with the Safety Risk Leads, the Risk-Management CoE, Medical Epidemiology and Big Data Analysis, Regulatory Affairs and the Asset Team to develop rationale, methodology, identification of data sources and integration within filing and maintenance strategies.
• Accountable for working in a closely aligned fashion with leaders from across WMS, in particular Medical Epidemiology and Big Data Analysis, to ensure there is a single and coordinated view on pharmaco-epidemiology strategy, and that Medical Epidemiology and Big Data Analysis is the single point of accountability for the delivery of RWD epidemiology and big data analysis integrated plans.
• Contributes to safety and pharmaco-epidemiology regulatory interactions to ensure compliance with global safety and risk-management regulations, in particular but not limited to FDA & EMA. Contributes to national and global organizations with vested interest in innovative techniques in safety surveillance research (ie ISPE, CIOMS, ICH, IMEDS, IMI, Transcelerate) . Demonstrates a global scientific mindset in the field.
• Engages and collaborates with external thought leaders in pharmaco-epidemiology and safety surveillance research  to ensure that Pfizer remains at the forefront of this field.
• Accountable for the development and implementation of policies on PASS within Pfizer.

​Leadership:

• Develops a clear strategy, sets standards, and implements a plan for Safety Surveillance Research in the WMS organization.
• Develops the members of the Safety Surveillance Research and Global Pharmacovigilance ensuring they have the necessary skills, capabilities, and experiences to deliver industry-leading analyses and insights.
• Models leadership behavior and inspires team to achieve goals with quality, compliance, speed, insight, and creativity.
• Establishes high standards of excellence, sets clear expectations, and holds him- or herself and all team members accountable for their actions.
• Acts decisively making effective decisions with urgency and removes barriers that hinder productivity.
• Accountable for ensuring projects are managed cost-effectively and per budget/timeline, can make trade-offs as necessary, and takes appropriate actions to de-risk decisions.
• Ensures that projects are appropriately prioritized and receive the resources and support to position them for success.
• Drive external recognition of Pfizer as both a leader and as a partner-of-choice for  safety surveillance research.    

  

Communication:

• Outstanding communicator who is able to adapt and deliver an effective presentation in a variety of settings.
• Able to clearly and accurately articulate strategy and tactics in a way that is appropriate for the audience.
• Encourages transparency and fosters an open dialogue with all stakeholders (inside and outside of Pfizer).

BASIC QUALIFICATIONS

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

• Education: Advanced degree in healthcare, health services research or analytics (Ph.D. or equivalent, or an MD/Ph.D.)
• Strong interpersonal and communication skills bridging scientific and business needs – integrating pharmaco-epidemiology, drug safety, pharmacovigilance, risk management and mitigation techniques, regulatory affairs.
• At least 15 years of relevant experience in the pharmaceutical, academic and/or medical environments plus experience with cutting-edge pharamcopharmaco-epidemiological and  safety surveillance research and their applications to drug development and lifecycle management.
• Knowledgeable of pharmaceutical clinical, safety, regulatory, competitive and environmental issues as well as relevant Health Authority guidelines.
• Executive presence, scientific credibility  and ability to interact effectively with all levels of the organization.
• Proven ability to lead teams, build coalitions and develop strong partnerships across disciplines and geographies in a matrix environment to optimize the function’s performance and contribution.          
• Must have excellent customer-service orientation and ability to think innovatively.
• Proven ability to devise and manage metrics/scorecards to measure effectiveness and productivity; strong analytic skills, including the ability to build qualitative and quantitative arguments.

 

Other Job Details:

Last Date to Apply for Job: September 24th, 2021

Additional Location Information: New York, NY; Collegeville, PA; Groton, CT; Cambridge, MA; Milan, Italy; Sandwich, UK; Cambridge, UK; Walton Oaks, UK

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Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Pfizer is an E-Verify employer.

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