Clinical Safety Specialist | $80/hr Remote

Position: Pharmacovigilance Expert Type: Contract Compensation: $70 - $80/hour Location: Remote Commitment: 10-40 hrs/week Role Responsibilities Author and review evaluation tasks based on DSURs, PSURs/PBRERs, and associated safety data. Assess the accuracy and adequacy of interval safety findings and signal evaluations. Ensure template and structural conformity to ICH E2F and ICH E2C requirements. Reconcile figures and case counts across report sections and data sources. Evaluate safety conclusions in light of new data or events. Deliver structured feedback for AI-driven pharmacovigilance documentation tools. Requirements Have strong relevant experience in pharmacovigilance or drug safety. Proficiency in authoring or reviewing DSURs and/or PSURs/PBRERs is required. Working fluency with ICH E2F, ICH E2C(R2), and GVP guidelines is essential. Hands-on experience with MedDRA coding and aggregate safety data analysis is necessary. An advanced degree in life sciences, pharmacy, nursing, or medicine is preferred. Application Process Easy Apply on LinkedIn Check email for next steps Participate in resume evaluation & interview stage

The role involves authoring and reviewing safety evaluation tasks based on DSURs and PSURs/PBRERs while ensuring conformity to ICH guidelines. Additionally, the specialist will reconcile safety data and provide feedback for AI-driven pharmacovigilance tools.

Candidates must have strong experience in pharmacovigilance, proficiency in aggregate safety reports, and fluency in ICH and GVP guidelines. An advanced degree in life sciences, pharmacy, nursing, or medicine is preferred.

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Pharmacovigilance
• Drug Safety
• DSUR Authoring
• PSUR/PBRER Authoring
• ICH E2F
• ICH E2C
• GVP Guidelines
• MedDRA Coding
• Aggregate Safety Data Analysis
• Signal Evaluation

• Healthcare
• Science & Research
• Manufacturing

Formation minimale

Maîtrise

Expérience minimale

2+ ans

Langue de l’offre

anglais

Heures de travail

40 heures par semaine

Niveau d’expérience

Associate

Mode de candidature

La candidature directe est offerte