Global Safety Physician
Moderna
Cambridge, MA
safety
regulatory
safety
pharmacovigilance
public health
health
research
medical
family
vaccines
manufacturing
science
risk management
August 8, 2023
Moderna
Cambridge, MA
FULL_TIME
The Role:
The Pharmacovigilance function maintains public confidence through globally compliant clinical safety and risk management for Moderna’s entire product portfolio including the mRNA-1273 vaccine from Phase 1 through Post Marketing. The Global Safety Physician reports to Moderna’s Vice President, Pharmacovigilance and performs clinical trial safety evaluation, post marketing surveillance, periodic regulatory reporting, risk management/minimization, and external communication with cross functional partners.
Here’s What You’ll Do:
Provide clinical and scientific leadership within the pharmacovigilance function.
Engage cross-functional internal workstreams including therapeutic area development, biostatistics, clinical operations, and regulatory affairs.
Engage with external organizations, key opinion leaders, and advisors
Guide the operations of contract research organizations
Perform case series analysis of adverse events and review of passive surveillance data mining signals of disproportionate reporting as well as safety issues from other sources
Lead clinical safety and benefit risk sections of regulatory documents and preparation for meetings with regulatory and public health authorities as well as advisory committees
Provide clinical input to the design of clinical trials, signal refinement/validation activities, post authorization studies, risk minimization, and risk communication
Here’s What You’ll Bring to the Table:
MD or non-US equivalent with residency training, board certification, and at least three years of clinical practice experience
Additional graduate training in public health, epidemiology, or statistics is preferred
Minimum two years’ experience in pharmacovigilance in an industry setting. Exceptional candidates from academic, regulatory, and clinical development settings will also be considered.
Proven ability to:
Collaborate within technical teams to deliver high-quality results within established timelines
Utilize technology supporting pharmacovigilance
Integrate concepts and guidelines from FDA, EMA, PMDA and other regulatory agencies, public health agencies and nongovernmental organizations, and clinical practice groups
Investigate new safety issues
Communicate medical product benefits and risks to regulatory and public health authorities as well as the public
Ability to thrive in a fast-paced environment while providing appropriate attention to detail
Excellent analytical, problem-solving, strategic planning, and interpersonal skills.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
Family care benefits, including subsidized back-up care options and on-demand tutoring
Free premium access to fitness, nutrition, and mindfulness classes
Exclusive preferred pricing on Peloton fitness equipment
Adoption and family-planning benefits
Dedicated care coordination support for our LGBTQ community
Generous paid time off, including:
Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
401k match and Financial Planning tools
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Complimentary concierge service including home services research, travel booking, and entertainment requests
Free parking or subsidized commuter passes
Location-specific perks and extras!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible . Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com .
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. #LI-MD3
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The Pharmacovigilance function maintains public confidence through globally compliant clinical safety and risk management for Moderna’s entire product portfolio including the mRNA-1273 vaccine from Phase 1 through Post Marketing. The Global Safety Physician reports to Moderna’s Vice President, Pharmacovigilance and performs clinical trial safety evaluation, post marketing surveillance, periodic regulatory reporting, risk management/minimization, and external communication with cross functional partners.
Here’s What You’ll Do:
Provide clinical and scientific leadership within the pharmacovigilance function.
Engage cross-functional internal workstreams including therapeutic area development, biostatistics, clinical operations, and regulatory affairs.
Engage with external organizations, key opinion leaders, and advisors
Guide the operations of contract research organizations
Perform case series analysis of adverse events and review of passive surveillance data mining signals of disproportionate reporting as well as safety issues from other sources
Lead clinical safety and benefit risk sections of regulatory documents and preparation for meetings with regulatory and public health authorities as well as advisory committees
Provide clinical input to the design of clinical trials, signal refinement/validation activities, post authorization studies, risk minimization, and risk communication
Here’s What You’ll Bring to the Table:
MD or non-US equivalent with residency training, board certification, and at least three years of clinical practice experience
Additional graduate training in public health, epidemiology, or statistics is preferred
Minimum two years’ experience in pharmacovigilance in an industry setting. Exceptional candidates from academic, regulatory, and clinical development settings will also be considered.
Proven ability to:
Collaborate within technical teams to deliver high-quality results within established timelines
Utilize technology supporting pharmacovigilance
Integrate concepts and guidelines from FDA, EMA, PMDA and other regulatory agencies, public health agencies and nongovernmental organizations, and clinical practice groups
Investigate new safety issues
Communicate medical product benefits and risks to regulatory and public health authorities as well as the public
Ability to thrive in a fast-paced environment while providing appropriate attention to detail
Excellent analytical, problem-solving, strategic planning, and interpersonal skills.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
Family care benefits, including subsidized back-up care options and on-demand tutoring
Free premium access to fitness, nutrition, and mindfulness classes
Exclusive preferred pricing on Peloton fitness equipment
Adoption and family-planning benefits
Dedicated care coordination support for our LGBTQ community
Generous paid time off, including:
- Vacation, sick time and holidays
- Volunteer time to participate within your community
- Discretionary winter shut down
- Paid sabbatical after 5 years; every 3 years thereafter
Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
401k match and Financial Planning tools
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Complimentary concierge service including home services research, travel booking, and entertainment requests
Free parking or subsidized commuter passes
Location-specific perks and extras!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible . Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com .
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. #LI-MD3
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