The Medical Assessment and Signal Detection Lead is responsible for the medical review, assessment, and approval of Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing. This role involves performing signal detection activities, working collaboratively with program safety leads, and ensuring quality in collaboration with the PV operations team. The Lead also supports Program Safety Leads with any tasks assigned by the Head of GPS Medical Science.
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.
Requirements- Doctoral degree required (e.g., MD, PharmD, PhD)
- 5+ years' experience in Pharma required including a thorough understanding of PV processes
- Expertise in safety surveillance, signal detection, regulatory compliance, and benefit-risk assessment.
- Working knowledge of FDA, EMA PV regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations.
- Strong collaboration and communication skills.
- Ability to work effectively in an agile and fast paced environment.
- Ability to travel up to 20% of the time domestically and internationally
This is a hybrid role operating preferably out of Palo Alto, CA; however, we welcome candidates to apply residing near our Princeton, NJ office.
The estimated salary range for this position is $220-235k DOE. Actual salary determination is dependent on a variety of factors some of which include: experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus or an incentive compensation plan (eligibility varies based on role and position level), discretionary stock-based long-term incentives, paid time off, and a comprehensive benefits package.
Benefits- 401(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
