Head of Patient Safety – Remote Position Available In Montgomery, Pennsylvania

Job Description:

We go where others won’t, taking on some of the biggest publichealth challenges to protect and enhance millions of lives, andcreate a better, more secure world. Here, you will join passionateprofessionals who advance their scientific, technical andprofessional skills to develop products designed-to protect andenhance life. Job Summary Head of Patient Safety will serve as thekey medical leader overseeing all aspects of product safety acrossthe organization. This role is responsible for developing andexecuting the patient safety strategy in alignment with thecompany’s overall scientific and product strategy, ensuring aproactive and integrated approach to risk management across theportfolio. The Head of Patient Safety will work across bothcommercial and clinical product portfolios to evaluate and balanceproduct benefits and risks while ensuring compliance with globalregulatory requirements. They will lead the development,implementation, and continuous improvement of pharmacovigilanceprocesses, signal detection, risk evaluation, and mitigationstrategies. This leader will work cross-functionally withRegulatory, Medical Affairs, Clinical Development, Quality, andCommercial teams to embed a strong safety culture, enhancebenefit-risk assessments, and ensure the highest standards ofpatient safety throughout the product lifecycle. EssentialFunctions Reasonable accommodations will be made to enableindividuals with disabilities to perform the essential functions.

• Lead the patient safety strategy, ensuring an integrated andproactive approach to risk management across the organization.
• Serve as the key medical voice on safety-related matters,representing the company to regulatory agencies, professionalorganizations, and business partners.
• Chair or co-chair theGlobal Safety Committee, driving cross-functional collaboration tomaintain high standards of patient safety.
• Overseepharmacovigilance activities to ensure compliance with U.S. andglobal regulatory requirements for both investigational andmarketed products.
• Direct the integration of pre- andpost-marketing safety surveillance with Clinical Development andMedical Affairs, ensuring a comprehensive approach to riskmanagement.
• Provide oversight for the identification, assessment,and communication of safety signals, implementing appropriate riskmitigation strategies.
• Ensure the quality and accuracy of alldrug safety programs and deliverables, including adverse eventreporting, safety assessments, and regulatory submissions.
• Guidethe development and execution of risk management plans, includingRiskMAPs and REMS, to optimize product benefit-risk profiles.
• Oversee the preparation and review of safety-related regulatorydocuments, including ICSRs, INDs, NDAs, annual reports, andPSURs/DSURs/PBRERs.
• Partner with Clinical Development, MedicalAffairs, Regulatory, and Quality teams to embed a strong safetyculture and ensure alignment on safety-related initiatives.
• Provide strategic leadership in the evaluation of benefit-riskassessments for development and commercial products.
• Ensure allsafety activities align with ethical standards, industryregulations, and corporate objectives.

The above statements areintended to describe the nature of work performed by those in thisjob and are not an exhaustive list of all duties. Nothing in thisjob description restricts managements right to assign or reassignduties and responsibilities to this job at any time which reflectsmanagement’s assignment of essential functions. Minimum Education,Experience, Skills

• MD with 10 years of experience inpharmacovigilance, clinical development, medical affairs,regulatory, and quality on a global level.
• Proven leadershipexperience as head of the pharmacovigilance function inbiotechnology or pharma, with a track record of success.
• Expertise in pharmacovigilance with deep knowledge of regulatoryrequirements and guidelines pertaining to drug safety.
• Experiencebuilding and developing high-performing teams
• Strong analyticalskills with the ability to critically interpret and applyscientific and clinical data for risk assessment and management.
• Proficient understanding of epidemiology and statistics, with theability to apply data-driven decision-making.
• Excellentcommunication skills, both oral and written, with the ability toinfluence internal and external stakeholders.
• Ability to thrivein a matrixed environment, effectively collaborating acrosscross-functional teams including Regulatory, Clinical Development,Medical Affairs, Commercial, and Quality.
• Strong problem-solvingand critical thinking abilities, with a demonstrated ability tomanage complex issues and competing priorities.
• Experience in afast-paced, deadline-driven environment, with the ability to managemultiple priorities simultaneously.
• Commitment to business ethicsand compliance, ensuring alignment with corporate values, industryregulations, and best practices.

U.S. Base Pay Ranges and BenefitsInformation The estimated annual base salary as a new hire for thisposition ranges from $267,500 to $323,600. Individual base paydepends on various factors such as applicant’s education,experience, skills, and abilities, as well as internal equity andalignment with market data. The salary may also be adjusted basedon applicant’s geographic location. Certain roles are eligible foradditional incentive compensation, including merit increases,annual bonus, [and/or long-term incentives in the form of stockoptions.] (

• Eligibility for benefits is governed by the applicableplan documents and policies).

If you are selected for an interview,please feel welcome to speak to a Human Resources Partner about ourcompensation philosophy and available benefits. There arephysical/mental demands and work environment characteristics thatmust be met by an individual to successfully perform the essentialfunctions of the job. This information is available upon requestfrom the candidate. Reasonable accommodations may be made to enableindividuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative ActionEmployer and values the diversity of our workforce. Emergent doesnot discriminate on the basis of race, color, creed, religion, sexor gender (including pregnancy, childbirth, and related medicalconditions), gender identity or gender expression (includingtransgender status), sexual orientation, age, national origin,ancestry, citizenship status, marital status, physical or mentaldisability, military service or veteran status, genetic informationor any other characteristics protected by applicable federal, stateor local law. Emergent BioSolutions does not accept non-solicitedresumes or candidate submittals from search/recruiting agencies notalready on Emergent BioSolutions’ approved agency list. Unsolicitedresumes or candidate information submitted to Emergent BioSolutionsby search/recruiting agencies not already on Emergent BioSolutions’approved agency list shall become the property of EmergentBioSolutions and if the candidate is subsequently hired by EmergentBioSolutions, Emergent BioSolutions shall not owe any fee to thesubmitting agency.