Manager, Safety Surveillance Research Scientist

All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. As we continue to create breakthroughs that change patients' lives, we are looking for new talents.
Right now, we are seeking highly qualified candidates to fill the position:
Manager Safety Surveillance Research Scientist
ROLE SUMMARY
Under the guidance of the Safety Surveillance Research (SSR) unit lead, this role develops and executes post-approval pharmacoepidemiology/real world evidence research strategies to assess potential safety risks and investigate new safety signals, assess effectiveness of risk management, ensure compliance with global regulatory commitments, and inform benefit-risk decisions about Pfizer medicines.
ROLE RESPONSIBILITIES
Under the guidance and supervision of the SSR unit lead, and with the review and approval of all deliverables by SSR management, the SSR scientist will

• Contribute to the design and implementation of real-world, de novo , or hybrid design studies intended to quantify risks potentially associated with Pfizer products or to assess the effectiveness of risk mitigation activities. Complexity of study designs will be lower in comparison to other levels within the SSR organization.
• Contribute to the development of post-approval safety studies required as a condition for product approval or to investigate signals arising post-approval. Volume and complexity of these studies will be lower in comparison to other levels within the SSR organization.
• Contribute to the design and implementation of other epidemiology strategies to investigate safety signals arising post-approval, such as critical review of publication on Pfizer products and real-world data queries
• Build skill set to adequately interact with regulatory agencies on safety epidemiologic issues as needed, via written and/or verbal communications
• As appropriate and with managerial oversight, consult on safety-related issues in pre-approval research strategies, such as defining safety endpoints in standing cohorts
• Participate in Risk Management Committee activities related to post-approval epidemiology strategies as needed
• Contribute to epidemiology sections of risk management plans with appropriate oversight from unit lead and/or senior SSR colleagues
• Support vendor management oversight activities, as applicable, with appropriate oversight from unit lead and/or senior SSR colleagues
• Present and publish results of safety epidemiological studies at scientific conferences and peer-reviewed journals
• Work collaboratively with key stakeholders internally (such as Safety Risk Leads, RM CoE Leads, Clinical, Medical, Regulatory) and externally (such as academics, regulators, vendors)
• Support other SSR colleagues as required
• As appropriate and with managerial oversight, consult on design of key post-approval safety studies required by single-country health authorities outside the US and EU
• May be responsible for negotiating and overseeing observational study budgets
• Participate in internal and external initiatives related to safety epidemiology

BASIC QUALIFICATIONS
Candidate demonstrates a breadth of diverse experiences and capabilities including: the ability to learn quickly, adapt to a rapidly changing environment, and influence and collaborate with peers to achieve meaningful outcomes and create business impact.

• Doctoral degree in Epidemiology/Quantitative Public Health Discipline or Doctor of Medicine (MD or equivalent) with a Master's degree in Epidemiology/Quantitative Public Health Discipline
• Experience from the pharmaceutical industry, academia, and/or regulatory agencies
• In-depth understanding of and expertise in epidemiologic methods, including observational and experimental study designs and analysis, and appropriate sample size calculation methodology
• Experience writing epidemiological sections of scientific documents such as research summaries, publications, grant proposals, risk management plans, etc.
• Independently serve as safety research lead of projects with some regulatory/methodologic complexity such as enhanced surveillance or drug utilization; or for less complex projects, lead independently with minimal mentorship

PREFERRED QUALIFICATIONS

• Practical experience with implementation of observational or experimental studies
• Demonstrated ability to negotiate scientific and operational decisions with cross-functional teams, external collaborators;, and support regulatory interactions
• Experience in applying epidemiologic methods to study the safety of medicines preferred
• Experience participating in internal strategic initiatives and/or representing Pfizer in select external initiatives

Other Job Details:
This role is to be site based in Europe, at any current Pfizer location. Flexibility home office/site is 50-50. You will be part of a global team and manager is located in the US.
There is no relocation assistance available for this position.
Join us in making breakthroughs that change patients lives.
We are looking forward to your CV/resume and cover letter in English as soon as possible.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
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