Global Safety Physician, GPS - The Steely Group

The Global Safety Physician (GSP) is a leadership role within the Global Patient Safety organization accountable for executing the safety and risk management activities for clinical development and marketed products to enable the safe and effective use of the client's products by patients and healthcare providers. The GSP represents the medical safety function in relevant business processes and committees, both in clinical development and in the postmarketing space, to ensure consistency of safety focus, methods, and communications. This includes working closely with colleagues within the GPS Medical Risk Management team (MRM) and cross-functional teams to provide internal safety representation to the development teams, conduct review of partner scientific & medical deliverables, and other activities associated with structured benefit risk assessment of assigned assets. Overall responsibilities for this role include leading, overseeing, and contributing to the safety and benefit-risk evaluations for assigned products, the management of potential safety issues, evaluation of databases for safety signals, and other activities such as drafting of responses to regulatory inquiries on product safety issues. The role of the GSP involves collaboration with business partners that hold licenses in global regions.

Responsibilities:

• Oversight of the medical review of individual adverse event reports for the clients products, both from clinical trials and post-marketing, for seriousness, expectedness, and causality, adhering to documented procedures and company/vendor timelines, completion of Analysis of Similar Events for IND Safety Reports, and completion of Investigator Safety Letters
• Oversight of and close collaboration with the MRM team for various safety-related activities
• Lead and/or participate in the identification and assessment of potential safety signals for the clients products and communication to the relevant safety governance bodies
• Provide medical interpretation of information from various sources to inform the safety profile of the clients products, such as clinical trial and postmarketing adverse events and safety information, nonclinical and toxicology information, scientific literature, and product quality complaints
• Lead and/or participate in development and maintenance of risk management plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS), as needed
• Collaborate with Business Partners on the exchange of safety data, safety monitoring and safety profiles, as laid out in Pharmacovigilance Agreements
• Provide consultation for medically related questions from participating vendors, Partners, etc.
• Lead the medical safety strategy and/ or draft safety sections for aggregate reports (e.g., DSUR, PBRER/PSUR, PADER), regulatory requests, and signal assessments, as necessary
• Provide medical safety input for Investigator's Brochures (IBs), protocols, Case Report Forms (CRFs), IND and NDA submissions, Product Labels, Annual Safety Reports, and other regulatory documents and communications
• Provide clinical and strategic input to the design of clinical trials, signal refinement/validation activities, post authorization studies, risk minimization, and risk communication. This includes collaborating with Clinical Research, Clinical Operations, Medical Scientific Affairs, and/or vendors to develop and monitor the clinical trial safety.
• Lead, contribute, and/or review of safety related deliverables for marketing applications such as ISS, SCS, CO, nonclinical overview, and patient narratives. Provide critical review and input to applicable statistical analysis plans along with review and interpretation of data outputs
• Responsible for development of documents and for negotiation with Regulatory Authorities on safety matters involving the clients products. This includes but is not limited to direct interaction with Regulatory Authorities, expertise in preparing regulatory responses to the Pharmacovigilance Risk Assessment Committee (PRAC) and other Health Authorities, and oversight and/or authorship of safety summaries to support changes to labeling.
• Integrate concepts and guidelines from FDA, EMA and other regulatory agencies, public health agencies and nongovernmental organizations, and clinical practice groups
• Contribute expertise in medical safety and pharmacoepidemiology to the development and maintenance of Pharmacovigilance Analytics systems and processes
• Closely collaborate with Clinical Operations, GPS Operations, Regulatory Affairs, and applicable vendors for seamless PV processes, serving as a leader, mentor and ambassador for GPS

Qualifications:

• Medical degree required or internationally recognized equivalent
• Minimum of 8-10 years of experience in pharmacovigilance, ideally within both postmarket and clinical safety
• Excellent written and communication skills, with demonstrated ability to communicate complex medical information to a variety of audiences
• Experience with regulatory agencies and key stakeholder interactions
• Knowledge of pharmacovigilance practices, particularly in relation to signal detection and evaluation and risk management, and of the regulatory requirements relating to pharmacovigilance in the US and internationally
• Excellent analytical, problem-solving, strategic planning, and interpersonal skills
• Familiarity with quantitative methods
• Proficiency in statistics, epidemiology, MedDRA coding, Microsoft Excel, Word, and PowerPoint; ability to learn new computer systems as they are implemented
• Demonstrated project leadership around pharmacovigilance activities with cross-functional teams in a multicultural environment