Pharmacovigilance Specialist (Remote)

Role: Pharmacovigilance Specialist (Remote) Location: Remote (Work from Anywhere) Job Type: Contract Payout: $70 - $80/hour Role Overview: We are hiring for one of our clients, seeking a Pharmacovigilance Expert to work on a contract basis. This role involves monitoring, evaluating, and reporting adverse events related to pharmaceutical products to ensure patient safety and regulatory compliance. The position requires meticulous documentation and adherence to global pharmacovigilance guidelines. Key Responsibilities: • Collect, review, and assess adverse event reports from various sources, including clinical trials and post-market surveillance. • Prepare and submit expedited and periodic safety reports to regulatory authorities in compliance with ICH-E2 guidelines. • Maintain comprehensive pharmacovigilance documentation and ensure traceability of case data. • Collaborate with cross-functional teams, including medical affairs and regulatory affairs, to evaluate safety signals and risk management plans. • Conduct quality assurance checks on pharmacovigilance processes to ensure compliance with SOPs and regulatory standards. Required Skills & Qualifications: • Experience in pharmacovigilance with a focus on adverse event reporting and case processing. • Proficiency in pharmacovigilance databases and systems for case management and reporting. • Strong knowledge of ICH-E2, GVP, and other relevant regulatory guidelines. • Excellent analytical and communication skills to interpret safety data and prepare regulatory submissions. • Ability to work independently in a remote setting with strong attention to detail and compliance. More About the Opportunity: This role offers a unique opportunity to work with a global leader in the Pharmaceutical Manufacturing industry, contributing to the protection of patient safety and regulatory compliance across multiple product lines. The position requires a high degree of accuracy and adherence to strict timelines for safety reporting. Equal Opportunity Employer: We hire based on skills and expertise. All qualified candidates are welcome regardless of background, experience, or prior employment history. Applications are reviewed solely on demonstrated technical ability and qualifications. Apply Now!

The role involves monitoring, evaluating, and reporting adverse events to ensure patient safety and regulatory compliance. Key tasks include preparing safety reports for regulatory authorities and collaborating with cross-functional teams to evaluate safety signals.

Candidates must have experience in pharmacovigilance, specifically in case processing and adverse event reporting. Proficiency in pharmacovigilance databases and strong knowledge of ICH-E2 and GVP guidelines are required.

• Assurance qualitéSouhaitée
• Regulatory ComplianceSouhaitée
• Communication SkillsSouhaitée

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

• Pharmacovigilance
• Adverse Event Reporting
• Case Processing
• ICH-E2 Guidelines
• GVP
• Regulatory Compliance
• Safety Signal Evaluation
• Risk Management Plans
• Quality Assurance
• Pharmacovigilance Databases
• Analytical Skills
• Communication Skills

• Healthcare
• Science & Research
• Manufacturing
• Security & Safety

Expérience minimale

2+ ans

Langue de l’offre

anglais

Heures de travail

40 heures par semaine

Niveau d’expérience

Associate