Job Description
Job Title: Pharmacovigilance Expert
Job Type: Contractor
Location: Remote
We are seeking experienced Pharmacovigilance Experts to contribute their drug safety expertise to an innovative healthcare AI project. In this role, you will help improve next-generation AI systems by reviewing, evaluating, and refining pharmacovigilance documentation, safety reports, and regulatory content. No prior AI experience is required—your pharmacovigilance expertise, analytical skills, and commitment to data quality are what matter most.
Key ResponsibilitiesAuthor and review evaluation tasks based on DSURs, PSURs/PBRERs, safety data, and case-level records.
Assess safety findings, signal evaluations, and benefit-risk conclusions for accuracy and regulatory alignment.
Review reports for compliance with ICH E2F, ICH E2C(R2), and GVP guidelines.
Analyze aggregate safety data and reconcile case counts, figures, and inconsistencies across data sources.
Evaluate safety conclusions based on new data, events, and regulatory requirements.
Provide structured written feedback and rationales to support AI-driven pharmacovigilance tools.
Ensure accuracy, completeness, and quality of regulatory safety documentation.
Pharmacovigilance
Drug Safety Report Authoring
DSUR/PSUR/PBRER Review
ICH E2F & ICH E2C(R2) Compliance
GVP Guidelines
Aggregate Safety Data Analysis
Signal Management
Benefit-Risk Assessment
MedDRA Coding
Seriousness & Causality Assessment
Expectedness Determination
Data Reconciliation
Regulatory Documentation
Structured Written Communication
Attention to Detail
5+ years of pharmacovigilance or drug safety experience within a sponsor, CRO, or consulting environment.
Proven experience authoring or reviewing DSURs and/or PSURs/PBRERs.
Strong knowledge of ICH E2F, ICH E2C(R2), and GVP guidelines.
Hands-on experience with signal management, benefit-risk assessment, MedDRA coding, and safety data analysis.
Experience reconciling aggregate safety data with case-level information.
Advanced degree in life sciences, pharmacy, nursing, medicine, or related fields (PharmD, MD, MSc, or equivalent).
Experience in clinical development safety, post-marketing surveillance, QPPV/deputy QPPV roles, safety committees, or AI-assisted safety review tools is a plus.
Company OverviewDocusign brings agreements to life. Over 1.5 million customers and more than a billion people in over 180 countries use Docusign solutions to accelerate the process of doing business and simplify peoples lives. With intelligent agreement management, Docusign...
...Proficient in Pharmacovigilance quality systems Maintains an extensive understanding of regulations and guidance as they pertain to drug safety and PV, including case processing, narrative and/or safety writing. Understands clinical trial processes. Independent Project...
Our Los Angeles office is looking for an experienced Senior Associate or Vice President the Media & Communications team, working across a broad range of high-profile transactions including M&A, strategic advisory, and capital markets. The role offers direct exposure to ...
...aprobadas de los clientes Identificar y reportar posibles reparaciones Desinfectar areas indicadas This job reports to the District Manager This is a Part-Time position 2nd Shift , 6:00PM to 10:00PM . Number of Openings for this position: 1
...This job posting is for a position in a restaurant owned and operated by an independent franchisee and not McDonalds USA. This franchisee owns a license to use McDonalds logos and food products, for example, when running the restaurant. However, this franchisee is a...