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Safety Event Management Strategist


2250 Perimeter Park Dr, Morrisville, NC 27560


Mercalis is the leading integrated commercialization partner for life sciences companies. We deliver end-to-end commercial solutions that work together to provide patient support services, healthcare provider engagement, and payer intelligence and strategic consulting. Backed by proven industry expertise and results-driven technology, Mercalis helps navigate the complex life sciences marketplace to accelerate value, enhancing business results and patient lives.

Mercalis fosters a culture that encourages individuality and provides opportunities for creativity, growth, and success. We are a diversity-driven team with an inclusive approach to delivering patient-centric solutions that eliminate barriers for patients, increase access to medications, and help patients receive life-saving treatments. At Mercalis, we believe happy, healthy people are passionate and engaged—and bring that attitude to work. We see ourselves as innovators, creators, and leaders that solve problems with visionary solutions.

Mercalis customers are legally required to comply with state and federal regulations and laws relating to Adverse Events, Product Complaints, and Other Safety Filings (collectively, “Reportable Events”).

As a vendor to those customers, Mercalis is contractually bound to report those Reportable Events to our customers to enable them to meet their legal and/or regulatory requirements.


  • Review Drug Safety submissions, review source data communications/transmissions, assure all required and pertinent information is requested and documented, provide feedback to internal team members, and ensure resubmissions are completed when discrepancies are identified.
  • Review all Mercalis systems that house Drug Safety data to ensure safety events are identified, documented accurately, and reported within client business requirements.
  • Demonstrate a working knowledge of Drug Safety documentation, reporting, and reconciliation practices.
  • Provide Subject Matter Expert (SME) knowledge into industry standards and provide consultative plans for specific program auditing related to reconciliations.
  • Interact, discuss findings, and work with team members to assure a shared knowledge base of efficiencies and findings.
  • Conduct miscellaneous tasks or projects as assigned by immediate supervisor.
  • Conduct daily, weekly, monthly, and/or quarterly reconciliations.
  • Complete Source Data Verification requests on a daily, weekly, monthly, and/or quarterly basis.
  • Build, establish, and maintain collaborate relationships with client-specific Drug Safety departments.
  • Review, research, and resolve client requests for clarification, review, and follow-up.


  • 1-2 years of related project/operations management experience in drug safety, team building, customer service, budgetary management, systems development, product development, and profitability maximization.
  • Possess strong mathematical and statistical skills.
  • Proven track record of delivering on-time projects and developing profitable business units.
  • Excellent consultative, listening, communication, and analytical skills.
  • Excellent interpersonal skills, including ability to interact across disciplines to facilitate effective and efficient teamwork.
  • Possess a team-oriented approach to accountability and results.
  • Bachelor’s Degree from an accredited university or equivalent experience required.
  • Ability to manage priorities.
  • Ability to make independent decisions to a defined limit.
  • Must be able to analyze data and make decisions.
  • Positive/Professional demeanor.
  • Display a high level of professionalism, integrity, and maturity.
  • Must be able to interact effectively with all levels of the organization.
  • Excellent interpersonal skills, including ability to interact across disciplines to facilitate effective and efficient teamwork.
  • Strong planning, attention to detail and organizational skills.
  • Ability to handle and maintain confidential information.
  • Flexibility.
  • Punctuality and Reliability.
  • Ability to operate with minimal supervision and guidance.
  • Excellent consultative, listening, communication, and analytical skills.
  • Solid technical writing skills; ability to clearly and completely articulate work to be done and describe tasks using proper terminology.
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