Director, Medical Safety Science

2 weeks ago

Palo Alto, United States Ascendis Pharma Full time
Job DescriptionJob Description

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.

Medical Safety Science Director reports to Head of Global Medical Safety Science. Under the direction of Head of Global Medical Safety Science, is responsible for all assigned 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 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 safety monitoring activities.
  • Adopt a leadership role for assigned products (development and post marketing) and work closely with Head of Global Medical Safety Science and Head of Global PV Operations in activities for monitoring patient safety, e.g., adverse event reports for potential safety related issues and provide recommendations when potential issues are identified.
  • 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.
  • Provides leadership to 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.).
  • 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 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
  • 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.
  • Under the direction of Head of Global Medical Safety Science, lead responses to ad-hoc safety queries from Regulatory Authorities in a timely manner and ensure the stakeholders are involved in crafting and tracking the responses.
  • Participate in relevant crisis management activities within the scope of Ascendis PV group.
  • Works closely with Head of Global Drug Safety, EU QPPV and colleagues in the US to be aware of all safety issues/concerns and provide consultation when needed.

Requirements

  • Doctoral degree required (e.g., MD or equivalent, PhD, PharmD)
  • 8+ 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
      • Estimated salary: $225-245K/year

A note to recruiters:

We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.

Benefits

  • Medical insurance
  • Vision insurance
  • Dental insurance
  • 401(k)
  • Paid maternity leave
  • Paid paternity leave
  • Commuter benefits
  • Disability insurance

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