Temp - Associate Director, Aggregate Reporting, GPS
Job Title: Temp - Associate Director, Aggregate Reporting, GPS Type: Contract Compensation: $85 - $100 hourly (dependent on experience) Contractor Work Model: Remote Highlights should include: 1. Pharmacovigilance & Aggregate Reporting Expertise
- Direct experience authoring or overseeing PSURs, PBRERs, DSURs, RMPs, and other ICH-compliant safety reports.
- Familiarity with regulatory safety reporting guidelines (e.g., EMA, FDA, ICH E2E).
- Demonstrated ability to manage safety data extraction, review, and narrative development.
2. Regulatory Agency Interaction & Inspection Readiness
- Participation in regulatory inspections or audits focused on pharmacovigilance.
- Preparation of documentation for FDA, EMA, MHRA, or other agencies.
- Experience responding to health authority questions or findings.
3. Leadership & Cross-Functional Collaboration
- Oversight or mentorship of safety writers or aggregate report teams.
- Collaboration with Signal Management, Medical Safety, Clinical, Regulatory Affairs, and Biostatistics groups.
- Experience in matrix team environments and representing PV/reporting functions in governance meetings.
4. Systems & Process Knowledge
- Proficiency with PV databases (e.g., Argus, ArisGlobal) and reporting tools (e.g., Empirica Trace, Spotfire, SAS).
- Experience with quality documentation systems (e.g., Veeva Vault).
- Knowledge of SOP development, CAPAs, and compliance tracking.
5. Scientific/Medical Writing & Data Analysis
- Strong writing background for aggregate safety documents, with the ability to translate safety data into regulatory narratives.
- Experience analyzing adverse event trends, exposure data, and risk assessments.
- Ability to interpret clinical data to support benefit-risk assessments.
Temp - Associate Director, Aggregate Reporting, GPS
- Submit Candidate
- This position resides in the Global Patient Safety (GPS) organization of companyin the Case Evaluation & Reporting (CER) area and would be responsible for oversight and management of Aggregate Reports.
A typical day may include the following:
- * Drives development and maintenance of Aggregate Reporting (i.e., PSURs/PBRER, PAER, DSURs, SUSARs) Deliverables
- Leads Aggregate Report planning, production and distribution activities across GPS and other functions
- Provides expertise and guidance to authors and contributors of aggregate reports
- Responsible for maintaining compliance metrics and contributes to implementation of Corrective Action and Preventive Action (CAPA) for non-compliance
- Responsible for the implementation and management of effective structure, procedures and tools to ensure aggregate reports and other functional deliverables are completed timely and with high quality
- Oversee functional specifications of data requirements for aggregate deliverables from the safety and clinical databases
- Collaborates with Global Patient Safety (GPS) and with functional areas (Epidemiology, Clinical Development, Regulatory Affairs, Statistics, etc.) contributing to aggregate safety reports
- Assists in preparation and support of audits and inspections
- Provides oversight, and training as needed, of CRO respective activities in support of high quality and timely aggregate reports
- Assess Aggregate Reports requirements and complexity, to identify potential issues and information gaps and support resolution of any identified issues
- Lead the enhancement of Quality Control process for Aggregate Reports
This role may be for you if have:
- * Extensive knowledge of US, ICH, EU PV and GCP/GVP regulations
- Experience with CA Inspections (PV and GCP).
- Experience working with Alliance Partners
- Medical writing experience with regulatory documentation
To be considered for this opportunity, you are expected to have a minimum of a bachelor’s degree, Life Sciences preferred. Minimum 7+ years of pharmacovigilance experience with focus on authoring and management of Aggregate Reporting. System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #LI-LM1 Ref: #568-Clinical Apply tot his job Apply To this Job