Signal Detection/Management & Safety Surveillance
- Performs core signal detection and assessment activities throughout the product life cycle (including review of safety-related literature and quantitative signal detection). Demonstrates solid capability in utilizing available tools and data sources to investigate safety concerns, contributing to safety assessments with increasing autonomy and analytical insight.
- Leads SDRMs by reviewing and evaluating clinical data to support signal detection and escalate issues impacting key SMT activities, milestones, and documents to the SMT Chair.
- Executes strategy for signal evaluation (e. g. , case-series, literature review, health authority/claims databases), promotes cross-functional collaboration, authors comprehensive signal reports, and proactively manages and tracks signals within the signal management system, ensuring timely notification and engagement of all relevant stakeholders.
- Prepares/writes safety and risk management sections of aggregate safety documents (e. g. , DSUR, PBRER, PADER).
- Analyzes data and writes ad hoc responses to health authorities, including supporting local markets in responding to risk management-related queries from local HAs.
Clinical Development Product Support
- Contributes to the preparation/review of safety sections in clinical trial documents, such as protocols, clinical study reports (CSR), investigator brochures (IB) including reference safety information (RSI), informed consent forms (ICF), and contraception language, with oversight.
- Represents Patient Safety and supports safety strategy preparation at internal and external meetings (pre-submission, Advisory Committees, Scientific Advice, data monitoring committee, publications, etc. ).
Submission Planning & Postmarketing Product Support
- Executes on the safety strategy for regulatory filings, including contributing to safety strategy, key safety messages, and risk management approaches. Reviews and authors safety sections of marketing authorization applications (MAA), with oversight, including safety table shells, Integrated Summary of Safety (ISS), Summary of Clinical Safety (SCS), clinical overview, briefing documents, and initial product labeling (USPI, CCDS, SmPC). Contributes to ad hoc regulatory safety requests (e. g. , 120-day safety response updates) and obtains safety data to determine the impact of the safety issue on the products benefit/risk profile.
- Analyzes data and authors documentation as needed to support safety labeling updates to ensure labeling adequately reflects the emerging postmarketing safety profile.
- Supports the EU QPPV or other regional/local QP for safety issues on assigned products.
Risk Management Planning & Execution
- Responsible for the creation and update of the EDSR to proactively characterize emerging safety concerns during asset development, support Structured Benefit Risk, and define the strategy for Company Core Risk Management and gaining alignment with SMT/ governance, including collaboration with Epidemiology on risk minimization effectiveness, non-interventional research (NIR) activities for post-authorization safety studies (PASS).
- Develops and maintains global and EU local Risk Management Plans (RMPs) and understands in-licensing or pharmacovigilance agreements that may impact risk management activities.
- Develops and maintains core additional Risk Minimization Measures (aRMMs) and additional Pharmacovigilance Activities (aPVAs) globally and locally. Coordinates with local markets and vendors for complex (e. g. , Pregnancy Prevention Programs, Controlled Distribution Programs) and non-complex aRMMs (e. g. , educational materials).
Department Activities
- Leverages automation and innovation tools into day-to-day work, with an understanding of current processes and ability to evaluate and suggest digital improvements. Uses multiple data sources and AI generated outputs to support decisions.
- Supports preparation for regulatory inspections and audits with evaluation of current processes and assesses alignment with regulatory expectations, guidelines, and mandates.
- Participates in team activities by engaging with TA staff and contributing to a collaborative working environment through consistent communication and professional conduct.
Cross Functional Activities
- Collaborates on and identifies opportunities for process improvement and cross-functional initiatives for Patient Safety Science, including update/maintenance of procedural documents.
- Builds cross-functional partnerships with SMT and ACT membership and stakeholders.
- Maintains solid knowledge of product goals, strategy, drug development milestones, partnership agreements, HA commitments, functional area responsibilities, and relevant global HA regulations; shares with cross-functional teams as needed.
- Scientific degree (e. g. , BS, MS, RN, PharmD, PhD, MD) or other degree with the equivalent combination of relevant education and professional experience
- Minimum of 4-6 years of relevant pharmacovigilance / pharmaceutical industry/drug development experience
- Working understanding of medical concepts and familiarity with safety activities in drug development and postmarketing and global safety health authority requirements.
- Working understanding of team priorities and milestones. Ability to manage timelines and quality of work through communication, cross-functional collaboration, and organizational skills, appropriately communicating items that could impact timelines or quality.
- Adaptable / flexible; willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism.
- Applies attention to detail along with strong scientific, analytical, and conceptual skills and scientific training to understand complex medical-scientific data across disciplines (e. g. , clinical and nonclinical data, postmarketing reports, scientific literature, and regulatory documents).
- Understands aspects and methods for data analysis, interpretation, and presentation, including an understanding of basic statistics, with basic ability to begin applying emerging technologies (AI, automation tools, and digital platforms) to streamline workflows, enhance data analysis, and reduce manual effort to ensure compliance with safety standards.
