Manager, PV Global Safety Systems & Analytics - Remote

Company: Emergent BioSolutions
Location: Gaithersburg
Posted on: November 6, 2024

Job Description:

Manager, PV Global Safety Systems & Analytics - RemoteLocation: Gaithersburg, MD, US, 20879We 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 SUMMARYThe position will support leadership with effective oversight and maintenance of the Global Pharmacovigilance Patient Safety Systems and Analytics Activities and will report directly to the Sr. Manager, Global PV Safety Systems within Global PV Patient Safety and Epidemiology.

• Possess knowledge of the Global Patient safety database for end-to-end IT service delivery starting from strategy formulation to execution.
• Maintains expertise in PV concepts and the safety systems landscape to support processes starting from AE/PC and inquiry intake to submissions, Periodic Reporting for Safety and Risk Assessment as applicable, System Upgrades, Data Migrations and Divestitures, Product Integration, Reporting distribution rules and other related data system activities.
• Proficient analytical skills and technical expertise supporting safety surveillance activities, signal detection, benefit-risk assessment, and epidemiology.ESSENTIAL FUNCTIONSReasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.Provide support to Global Patient Safety Systems, PV Operations and Medical Safety Evaluation Strategy (MSES):
• Patient Safety Systems:

• Support the Global Patient Safety Systems to maintain and update the Safety Systems per global regulations and as needed for process streamlining and improvement.
• Represent and collaborate with the internal and external business users, IT, QA, and vendors, supporting the evaluation of the safety database and associated reporting and signaling tools.
• Serve as a system administrator and perform configurations/master data updates like code lists, user access, reporting rules, products, and studies.
• Perform quality checks on Safety System configuration changes performed by the database service provider; identify discrepancies between the request and the implementation and resolve or initiate resolution.
• Participate in the process of qualification/validation of global safety database applications.
• Analytics:
  • Conduct and is responsible for generating formal reports, summaries, and listings supporting safety monitoring, signal detection, and aggregate reporting deliverables (PBRER, DSUR) in conjunction with the database service provider.
  • Support and contribute to safety signal or benefit-risk assessment by supporting safety data management and analytics.
  • Collaborate with Medical Safety and Epidemiology for reviews and analyses of safety data for assigned products to identify potential safety concerns or trends.
  • General:
    • Provide support to global end-users and ensure understanding of their needs.
    • Author/support system related Standard Operating Procedures (SOPs)/Working Instructions (WIs).
    • Serve as subject matter expert (SME) for audits and inspections as needed.
    • Perform other safety system related activities, as needed or as requested by supervisor.
    • Debug complex IT problems in partnership with IT and/or system vendor(s) where applicable.
    • Maintain intelligence of current global regulations/guidelines for governance in reporting of pre-approved (investigational) and approved (post-marketing) events to advise on safety system design and configuration.
    • Takes a 100% hands-on approach in project execution, ensuring that strategic decisions are implemented effectively and efficiently.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 management's 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
    • BS/MS in Computer Science/Programming/equivalent qualification with minimum of 5 years of relevant Pharmacovigilance safety systems and analytics industry experience.
    • Experience supporting Oracle Argus Safety is required. Additionally, work experience with Oracle Cloud and Empirica Signal and Topics is preferred. Training in Biostatistics or Epidemiology is a plus.
    • Proven experience and success as an analytical thinker with proficiency working with other data analysis platforms.
    • Experience in safety reporting applications is required. Knowledge of OBIEE is preferred.
    • Relational database knowledge working with Oracle and SQL is required.
    • General knowledge of Software Development Lifecycle (SDLC) and experience performing qualification/validation is required.
    • General knowledge of Electronic Data Interchange (Axway B2Bi Interchange in particular a plus) is required.
    • Good general knowledge about the global safety reporting requirements and ICH E2B guidelines that govern the global reporting of adverse events on investigational and marketed products are preferred.
    • Proven ability to understand and execute projects by prioritizing, planning with appropriate relevant individuals, remaining transparent, well organized and ensuring time management efficiency until project completion.
    • Demonstrates excellent oral, written communication and analytical skills, is attentive to details and timelines.
    • Must be flexible and this position may require working outside of regular hours to accommodate business needs, ensuring timely and effective delivery of objectives.Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.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.Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.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.ABOUT EMERGENTProtecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.Our drive towards this vision informs all of our actions-whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community-we strive every day to achieve this shared goal.WE BELIEVE IN OUR VALUES
      • Lead with Integrity
        • We gain trust and confidence through ethics, quality, and compliance excellence.
        • Stand shoulder to shoulder no matter what
          • We combine our best thinking and communicate openly to support each other.
          • Own it always
            • Every person at Emergent is engaged and accountable for delivering on our commitments.
            • Break through thinking
              • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
              • Compete where it counts
                • We set the right goals and respect each other as we conquer them together.
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