Associate Director Medical Safety Science - Job ID ADMSS
Associate Director Medical Safety Science - Job ID ADMSS
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Job Description
Ascendis Pharma is a dynamic fastgrowing global biopharmaceutical company with locations in Denmark Europe and the United States. Today were 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 bestinclass 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.
Associate Director Global Patient Safety Medical Science reports to Head of GPS Medical Science. Under the direction of Head of GPS Medical Science is responsible for all assigned Ascendis patient safety related activities for all products in the Ascendis portfolio. This successful candidate must be able to work out of an Ascendis office (Palo Alto CA or Princeton NJ) 3 days/week and 2 days remote.
Key Responsibilities
- Assists Head of GPS Medical 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 GPS direction standards and processes for supporting corporate safety monitoring activities.
- Conducts medical review assessment and approval of ICSRs from clinical trials and postmarketing.
- Ensures that all safety reports received from any source are reviewed according to ICHGCP 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 nonclinical 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. 15day 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.
Adhoc activities
- Under the direction of Head of GPS Medical Science leads 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.
Requirements
- Health Care Professional degree required (e.g. B. Pharm PharmD PhD)
- 5 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: $215225K/year DOE
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
- 401(k) plan with company match
- Medical dental and vision plans
- Companyoffered Life and Accidental Death & Dismemberment (AD&D) insurance
- Companyprovided short and longterm 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
Required Experience:
Director
Employment Type
Full-Time
