Associate Director, Medical Safety Science - Job ID: 1459

Ascendis Pharma is

a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.

Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.

Guided by our core values of Patients, Science, and Passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.

Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.Key ResponsibilitiesAssists Head of Global Medical Safety Science for drug safety and pharmacovigilance activities for ensuring corporate compliance with all applicable laws and regulations and as appropriate, local and foreign regulatory reporting requirements and for signal detection, evaluation and risk management.Supports Pharmacovigilance Department direction, standards, and processes for supporting corporate safety monitoring activities.Ensures that all safety reports received from any source are reviewed according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures.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.Supports the development of safety surveillance and risk management plans for drug development programs.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.).Assists in the preparation and revision of company product labeling as appropriate.Assists in the preparation and review of safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/CTD submissions and other relevant documents to ensure the safety profile of the products are reflected accurately.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.Ad-hoc activitiesUnder the direction of Head of Global Medical Safety Science, lead 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.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.RequirementsHealth Care Professional degree required (e.g., B. Pharm, PharmD, PhD).8+ years' experience in Pharma required including a thorough understanding of PV processes.Working knowledge of FDA, EMA PV regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations.Ability to travel up to 20% of the time domestically and internationally.Estimated compensation: 215-225K/year DOE.Benefits401(k) plan with company match.Medical, dental, and vision plans.Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance.Company-provided short and long-term disability benefits.Unique offerings of Pet Insurance and Legal Insurance.Employee Assistance Program.Employee Discounts.Professional Development.Health Saving Account (HSA).Flexible Spending Accounts.Various incentive compensation plans.Accident, Critical Illness, and Hospital Indemnity Insurance.Mental Health resources.Paid leave benefits for new parents.Seniority level:

DirectorEmployment type:

Full-timeJob function:

Management and ManufacturingIndustries:

IT Services and IT Consulting

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