Medical Global Safety Officer

Cambridge, MA


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We are currently searching for a skilled professional to join a well-known client’s team as Medical Global Safety Officer in Cambridge, Massachusetts. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.


  • Providing PV and risk management expertise to internal and external customers
  • Maintaining knowledge of product, product environment, and recent literature
  • Maintaining PV expertise, and understanding of international safety regulations and guidelines
  • Leading cross functional Safety Management Teams (SMTs)
  • Communicating with and represent PV position within project/product teams, with external partners, and key opinion leaders
  • Providing strategic and proactive safety input into development plans
  • Responsible for signal detection and analysis
  • Identifying and implementing proactive safety analysis strategies to further define the safety profile.
  • Lead aggregate safety data review activities and coordinate safety surveillance activities
  • Risk Assessment/Risk Management/ Benefit-Risk Assessment:
  • Providing proactive risk assessment
  • Co-leading benefit-risk assessment with other relevant functions
  • Representing safety position in cross functional submission teams
  • Ensuring generation, consistency, and quality of safety sections in submission documents
  • Writing responses or contributions to health authorities
  • Supporting preparation of Advisory Committee meetings
  • Documenting, coordinating, reviewing, and validating periodic reports, e.g.: RMP update, Development Safety Update Report, Periodic Benefit Risk Evaluation Report
  • Serving as the medical safety expert to the GPE Periodic Reports group for assigned projects and products


  • Minimum 3 years total experience in international pharmacovigilance
  • Board Certified/Board eligible, or equivalent


  • MD Degree required

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource 

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately

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