Medical Assessment and Signal Detection Lead (MD) GPS Medical Science- ID:2006b

Key Responsibilities: Conducts medical review, assessment, and approval of ICSRs from clinical trials and post-marketing. Supports Pharmacovigilance Department direction, standards, and processes for supporting corporate safety monitoring activities. Performs Quality Control reviews of assigned cases to ensure the accuracy, integrity, medical reviews and completeness of information entered in the safety database as needed. Liaises with Medical Monitors in Clinical Development to ensure that appropriate medical review and assessment is provided for adverse event reports and non-clinical safety findings. Assumes responsibility for the analysis, identification and reporting of possible trends and concerns regarding Ascendis products, and key competitive products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety. Provides medical and safety input to the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual Report, etc.).Collaborates with and provides pharmacovigilance guidance and support for interdepartmental and/or corporate initiatives. Provides pharmacovigilance expertise to Ascendis or CRO/Vendor staff when needed. Additional Activities Under the direction of Head of GPS Medical Science, may lead or contribute to responses to safety queries from Regulatory Authorities in a timely manner and ensure the stakeholders are involved in crafting and tracking the responses. Monitors industry best practices, changes in global safety regulations and guidelines for marketed and investigational projects and recommends changes and upgrades to existing departmental policies, SOPs and systems. Supports preparation and maintenance of departmental policies and SOPs that address the processing, analysis and reporting of safety information to ensure proactive surveillance of products in development. Supports Program Safety Leads with tasks assigned by the Head of Medical Safety Science. Through coordination with Ascendis GCP and PV Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits.