Director, Pharmacovigilance Safety Evaluation

Company: Ascendis Pharma Inc.
Location: Palo Alto
Posted on: May 3, 2021

Job Description:

Director, Pharmacovigilance Safety Evaluation

Development Operations, Pharmacovigilance Safety Analysis Palo Alto, California, United States Full time

Director, Pharmacovigilance Safety Evaluation reports directly to Sr Director, Pharmacovigilance Safety Evaluation. Under the direction of Sr Director, PV Safety Evaluation, is responsible for all assigned U.S. Ascendis Drug Safety PV related activities for all products in the Ascendis portfolio. This individual has accountability for the assigned PV activities in Ascendis.

Key Responsibilities
Assists Sr Director, PV 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. Assists Sr Director PV Safety Evaluation and QPPV in activities for monitoring patient safety, e.g., adverse event reports for potential safety related issues and provides recommendations when potential issues are identified. Supports to 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 received and non-clinical safety findings reported. Liaises with Medical Monitors in the analysis, identification and reporting or 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. Assists in the development of safety surveillance and risk management plans for drug development programs. Supports 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.). Leads the negotiation of safety data exchange/pharmacovigilance agreements with license partners and distributors in support of process definition, monitoring and other roles as required by drug safety to perform the drug safety mission. 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. Collaborates with, and provides pharmacovigilance guidance and support for interdepartmental and/or corporate initiatives Ensures awareness and training of appropriate Company personnel and external groups of PV and Drug Safety principles, policies and SOPs. 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. Functions as a PV advisor to Ascendis Clinical Development Organizations, Medical Affairs, Commercial Organizations and PV staff. Provides pharmacovigilance expertise to Ascendis or CRO/Vendor staff when needed. Ensuring SP/vendor oversight under the guidance of Sr Director, PV Safety Evaluation and QPPV by developing and implementing SP Oversight plans as required by Ascendis PV SOPs. In case of safety queries received from local Regulatory Authorities, under the direction of Sr Director, Pharmacovigilance Safety Evaluation inform relevant local and global personnel and respond in a timely manner to ensure tracking of the responses. Participate in relevant crisis management activities within the scope of Ascendis PV group. Works closely with Sr Director, PV Safety Evaluation and EU QPPV to be aware of all safety issues/concerns and provide consultation when needed.
Requirements
Doctoral degree required (e.g., MD or equivalent, PhD, PharmD) 12+ years experience in Pharma required including a thorough understanding of PV processes Expert 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 Ascendis Pharma collects and processes personal data in accordance with applicable data protection laws. If you are a European Job Applicant see the privacy notice for further details.
Ascendis Pharma is proud to be an equal opportunity workplace and we believe that diversity and inclusion among our workforce is critical to our success as a global company. Individuals seeking employment at Ascendis Pharma are considered without regards to age, ancestry, color, gender (including pregnancy, childbirth, or related medical conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. All employment is decided on the basis of qualifications, merit and business need.

Keywords: Ascendis Pharma Inc., Palo Alto , Director, Pharmacovigilance Safety Evaluation, Other , Palo Alto, California