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ICSR (Individual Case Safety Report) Processing * Review, triage, and process safety reports from various sources. * Perform data entry in safety databases with accuracy and medical consistency ...

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Icsr Case Processing information

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How much do icsr case processing jobs pay per hour?

As of Jun 9, 2026, the average hourly pay for icsr case processing in the United States is $49.14, according to ZipRecruiter salary data. Most workers in this role earn between $38.46 and $55.53 per hour, depending on experience, location, and employer.

What are some common challenges faced in ICSR Case Processing, and how can new team members effectively navigate them?

One of the main challenges in ICSR Case Processing is managing high volumes of cases while ensuring accuracy and compliance with regulatory timelines. New team members may also find it challenging to interpret complex medical information and stay updated with evolving global pharmacovigilance regulations. To succeed, it is important to develop strong attention to detail, make effective use of standard operating procedures, and proactively seek clarification from experienced colleagues. Collaboration with medical reviewers and regulatory affairs teams is also key to resolving ambiguities and ensuring the quality of case submissions.

What is the difference between Icsr Case Processing vs Clinical Data Entry Specialist?

AspectIcsr Case ProcessingClinical Data Entry Specialist
CertificationsOften requires knowledge of ICSR regulations and pharmacovigilanceTypically requires data entry or clinical research certifications
Work EnvironmentPharmaceutical or biotech companies, clinical trial settingsResearch organizations, clinical sites, or CROs
Job FocusProcessing and managing individual case safety reports (ICSRs)Entering and verifying clinical trial data into databases

While both roles involve handling clinical data, Icsr Case Processing focuses on managing safety reports and pharmacovigilance, whereas Clinical Data Entry Specialists primarily input and verify clinical trial data. Understanding these differences helps in choosing the right career path or job search focus within the clinical research industry.

What are the key skills and qualifications needed to thrive as an ICSR Case Processor, and why are they important?

To thrive as an ICSR Case Processor, you need a solid understanding of pharmacovigilance principles, medical terminology, and regulatory requirements, typically supported by a life sciences degree or equivalent experience. Familiarity with safety databases like Argus or ARISg and proficiency in using MedDRA coding and case management systems are essential. Attention to detail, strong organizational skills, and clear written communication help ensure accuracy and efficiency in processing cases. These skills are crucial for maintaining compliance, safeguarding patient safety, and supporting the integrity of drug safety reporting processes.

What is ICSR case processing?

ICSR case processing refers to the handling and evaluation of Individual Case Safety Reports (ICSRs) within the pharmacovigilance process. These reports detail adverse events or side effects experienced by patients after using a pharmaceutical product. The processing involves data entry, assessment, coding, narrative writing, and submission to regulatory authorities. The main goal is to ensure patient safety and regulatory compliance by accurately documenting and reporting any potential risks associated with drugs. Professionals in this role play a crucial part in monitoring and improving drug safety worldwide.
Infographic showing various Icsr Case Processing job openings in the United States as of May 2026, with employment types broken down into 95% Full Time, and 5% Contract. Highlights an 76% In-person, and 24% Remote job distribution, with an average salary of $102,217 per year, or $49.1 per hour.

Senior Manager, PV Vendor Management Team - Job ID: 1946

Ascendis Pharma

Princeton, NJ • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 2 days ago

Job 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.
Are you passionate about patient safety and ready to be part of a fast-paced, global pharmacovigilance organization? Ascendis Pharma is seeking a Senior Manager with a passion for safety excellence and data compliance to support our growing portfolio.
The Role
The Senior Manager, PV Vendor Management Team reports to the Director, Head, PV Vendor Management Team within the Global Patient Safety (GPS) organization. Under the direction of the Head, PV Vendor Management Team is responsible for all Vendor Management related activities.
Key Responsibilities
Pharmacovigilance related responsibilities during the initiation, conduct and closure of Organized Data Collection programs for marketed products. These activities include, but are not limited to:
    • Liaise with functional units to identify Market Research Programs, Patient Support programs and other Organized Data Collection programs
    • Ensure all programs are identified and tracked appropriately throughout the program lifecycle (initiation, conduct and closure)
    • Provide strategic input on the conduct of program to ensure compliance with PV requirements (e.g. add applicable PV language to vendor contracts, establish AE exchange method & timelines, and more)
    • Ensuring SP/vendor oversight under the guidance of Head of PV Vendor Management
    • Accountable for maintaining oversight over Source data quality check [SDQC] activities and/ or Case Transmission Verification (CTV) activities and ensure tracking and timely completion
    • Raise or increase awareness, knowledge and understanding of pharmacovigilance requirements by conducting education/training sessions with functional partners / vendors as required
    • Monitoring SPs/vendors to identify areas of risk and develop strategy and action plans to ensure compliance
    • Overseeing and supporting implementation of CAPAs as necessary

Work Closely with Ascendis GVP Compliance team and Commercial organization as required to ensure oversight of SPs/vendors.
Oversee the vendors/service providers to ensure that they fulfill their accountabilities and responsibilities, which in includes, but is not limited to:
    • Responsible for assigned PV activities/projects and working collaboratively with other teams within Ascendis
    • Ensures that Adverse Events from Organized Data Collection programs involving Ascendis products be collected, reported, and handled in accordance with global/local regulatory requirements and company policies. Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience (as needed)
    • Functions as a PV advisor to Medical Affairs, Commercial Organizations and other relevant stakeholders as applicable
    • Ensures processes are adhered to that support on time and appropriate ICSR submissions
    • Provides pharmacovigilance expertise to Ascendis or Vendor staff when needed

Additional activities may include but are not limited to:
    • Maintains strong relationships and communication with key stakeholders, including Commercial leadership, and GPS leadership to address queries, share metrics, and discuss new program-related processes
    • Through coordination with Ascendis GVP Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits
    • Contribute to the maintenance of Ascendis Pharmacovigilance System Master File (PSMF)
    • Work collaboratively with ICSR Management, Clinical Trial, EU QPPVand Medical Safety Science team for assigned activities
    • Implementation Coordination activities and associated tracking as necessary
    • Maintain selected oversight of activities within the scope of Ascendis PV group under the direction of Head of PV Vendor Management (example: Local PV agreements, CRMs, NPP's, Digital Media etc.)
    • Participate in relevant crisis management activities within the scope of Ascendis PV group

Requirements
You hold a Bachelor's degree in a health-related discipline with progressive pharmaceutical industry experience in Pharmacovigilance and drug safety operations; experience supporting Data Collection Programs.
  • Minimum of 7 years of progressive Pharmacovigilance experience within the pharmaceutical industry.
  • Demonstrated knowledge of FDA safety regulations, ICH Guidelines, GVP requirements, and applicable global pharmacovigilance regulations and guidance.
  • Experience operating in cross-functional, matrixed environments with the ability to support operational execution, compliance oversight, and inspection readiness activities.
  • Ability to travel domestically and internationally up to 20% as business needs require.

As a person, you have/are:
  • A passion for advancing innovative therapies that address unmet medical needs for patients struggling with Rare Endocrine Diseases
  • Working independently, while having a strong ability to interact as an effective team player encouraging collaboration in a multifunctional and multidisciplinary team setting
  • Demonstrated ability to navigate uncertainty and adapt quickly to changing priorities
  • Proven track record delivering results in dynamic, fast-paced settings where clarity evolves over time
  • Demonstrating ownership, initiative and accountability

The estimated salary range for this position is $165k - $175k. 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

Ascendis Pharma is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees.
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.

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