View more categories View less categories Sector Consultancy/Private Sector Field Conservation science Discipline Statistics Job Level Senior level Salary Type Salary Employment Type Full time
We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
Job Summary
Head of Patient Safety will serve as the key medical leader overseeing all aspects of product safety across the organization. This role is responsible for developing and executing the patient safety strategy in alignment with the company's overall scientific and product strategy, ensuring a proactive and integrated approach to risk management across the portfolio. The Head of Patient Safety will work across both commercial and clinical product portfolios to evaluate and balance product benefits and risks while ensuring compliance with global regulatory requirements. They will lead the development, implementation, and continuous improvement of pharmacovigilance processes, signal detection, risk evaluation, and mitigation strategies. This leader will work cross-functionally with Regulatory, Medical Affairs, Clinical Development, Quality, and Commercial teams to embed a strong safety culture, enhance benefit-risk assessments, and ensure the highest standards of patient safety throughout the product lifecycle.
Essential Functions
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Lead the patient safety strategy, ensuring an integrated and proactive approach to risk management across the organization.
• Serve as the key medical voice on safety-related matters, representing the company to regulatory agencies, professional organizations, and business partners.
• Chair or co-chair the Global Safety Committee, driving cross-functional collaboration to maintain high standards of patient safety.
• Oversee pharmacovigilance activities to ensure compliance with U.S. and global regulatory requirements for both investigational and marketed products.
• Direct the integration of pre- and post-marketing safety surveillance with Clinical Development and Medical Affairs, ensuring a comprehensive approach to risk management.
• Provide oversight for the identification, assessment, and communication of safety signals, implementing appropriate risk mitigation strategies.
• Ensure the quality and accuracy of all drug safety programs and deliverables, including adverse event reporting, safety assessments, and regulatory submissions.
• Guide the development and execution of risk management plans, including RiskMAPs and REMS, to optimize product benefit-risk profiles.
• Oversee the preparation and review of safety-related regulatory documents, including ICSRs, INDs, NDAs, annual reports, and PSURs/DSURs/PBRERs.
• Partner with Clinical Development, Medical Affairs, Regulatory, and Quality teams to embed a strong safety culture and ensure alignment on safety-related initiatives.
• Provide strategic leadership in the evaluation of benefit-risk assessments for development and commercial products.
• Ensure all safety activities align with ethical standards, industry regulations, and corporate objectives.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.
Minimum Education, Experience, Skills
• MD with 10+ years of experience in pharmacovigilance, clinical development, medical affairs, regulatory, and quality on a global level.
• Proven leadership experience as head of the pharmacovigilance function in biotechnology or pharma, with a track record of success.
• Expertise in pharmacovigilance with deep knowledge of regulatory requirements and guidelines pertaining to drug safety.
• Experience building and developing high-performing teams
• Strong analytical skills with the ability to critically interpret and apply scientific and clinical data for risk assessment and management.
• Proficient understanding of epidemiology and statistics, with the ability to apply data-driven decision-making.
• Excellent communication skills, both oral and written, with the ability to influence internal and external stakeholders.
• Ability to thrive in a matrixed environment, effectively collaborating across cross-functional teams including Regulatory, Clinical Development, Medical Affairs, Commercial, and Quality.
• Strong problem-solving and critical thinking abilities, with a demonstrated ability to manage complex issues and competing priorities.
• Experience in a fast-paced, deadline-driven environment, with the ability to manage multiple priorities simultaneously.
• Commitment to business ethics and compliance, ensuring alignment with corporate values, industry regulations, and best practices.
U.S. Base Pay Ranges and Benefits Information
The estimated annual base salary as a new hire for this position ranges from $267,500 to $323,600. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.]
(*Eligibility for benefits is governed by the applicable plan documents and policies).
If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.
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