Talent.com
Meet Life Sciences
Senior Specialist, Global ICSRMeet Life Sciences • remote, brasil, Brasil
As candidaturas não são mais aceitas
Senior Specialist, Global ICSR

Senior Specialist, Global ICSR

Meet Life Sciences • remote, brasil, Brasil
Há +30 dias
Descrição da vaga

Title: Senior Specialist, Global ICSR Case Processing & QC

Department: Global Patient Safety

Overview:

Seeking an experienced Senior Specialist in Global ICSR Case Processing & QC to independently manage the processing and quality control of individual case safety reports (ICSRs), ensuring regulatory compliance and excellence in data accuracy, completeness, and quality. The role includes SAE reconciliation, meeting compliance and productivity targets, and supporting onboarding and training for new team members.

Key Responsibilities:

  • ICSR Case Processing: Manage case processing and quality control of ICSRs from diverse sources (e.g., clinical trials, post-market, literature) to ensure timely, accurate submissions to regulatory authorities.
  • SAE Reconciliation: Perform SAE reconciliations between safety and clinical databases, track progress, resolve issues, and escalate when necessary.
  • Quality & Compliance: Adhere to KPI and quality metrics, ensuring productivity and process improvement within ICSR management.
  • Decision-Making: Execute decisions in line with operational policies, SOPs, and work instructions.
  • Vendor/CRO Coordination: Ensure ICSR activities align with PV agreements and contracts.
  • Training & Onboarding: Develop and update training materials, onboard new team members, provide feedback, and support the onboarding process.

Qualifications:

  • Bachelor’s degree in life sciences, clinical medicine, nursing, pharmacy, or equivalent experience; advanced degree preferred.
  • Proficiency with Argus safety database and MS Office Suite.
  • Minimum 2 years of experience in drug safety/pharmacovigilance or relevant clinical experience. Preferred 5-8 years of experience
  • Strong understanding of global regulatory requirements (e.g., ICH, FDA, EMA, MHRA) for pharmacovigilance reporting.
  • Excellent communication, problem-solving, time management, and attention to detail.
  • Global cultural awareness and collaborative mindset.

Criar um alerta de emprego para esta pesquisa

Senior Specialist, Global ICSR • remote, brasil, Brasil

Vagas similares

Global Hubspot Sales Operations

CrispBrasil, BR

Do you enjoy working inside systems, fixing what’s broken, and making things run correctly?.Can you take messy, inconsistent data and turn it into something accurate, reliable, and usable?.Do you g... Mostre mais

 • Promovida

Liquidity Partnership Manager (LATAM)

OSLBrasil, BR

We are looking for an LP Partnership Manager to drive business development and build strong relationships with liquidity providers across key regions.This role will be instrumental in sourcing, onb... Mostre mais

 • Promovida

Sales Director ( Chinese Speaking)

USA Tech RecruitBrasil, Federative Republic Of Brazil, BR

Our client is seeking a Chinese speaking commercially driven Sales Director to lead and expand their business across Brazil.This role will be responsible for market development, strategic account g... Mostre mais

 • Promovida

Sales Director (Brazil)

D PrimeBrasil, BR

D Prime is a globally recognized online broker, empowering professional investors with access to multi-asset CFD trading across global markets.With operational hubs in Dallas, London, Sydney, Singa... Mostre mais

 • Promovida

Sales Director ( Chinese speaking)

Tech RecruitBrasil, BR

Our client is seeking a Chinese speaking commercially driven Sales Director to lead and expand their business across Brazil.This role will be responsible for market development, strategic account g... Mostre mais

 • Promovida

Senior Compliance Manager

BingXBrasil, Federative Republic Of Brazil, BR

Founded in 2018, BingX is a leading crypto exchange and Web3 AI company, serving over 40 million users worldwide.Ranked among the top 5 global crypto derivatives platforms and recognized as a pione... Mostre mais

 • Promovida

Sales Director ( Chinese speaking)

USA Tech RecruitBrasil, BR

Our client is seeking a Chinese speaking commercially driven Sales Director to lead and expand their business across Brazil.This role will be responsible for market development, strategic account g... Mostre mais

 • Promovida

Sales Director ( Chinese Speaking)

Tech RecruitBrasil, Federative Republic Of Brazil, BR

Our client is seeking a Chinese speaking commercially driven Sales Director to lead and expand their business across Brazil.This role will be responsible for market development, strategic account g... Mostre mais