Pharmacovigilance Transition Lead | PV Operations Expert

Clora; United States; Remote; USD 144,648 - 241,080; Full time

Job summary

A biopharmaceutical company is seeking an experienced Drug Safety / Pharmacovigilance Operations expert to lead the transition of pharmacovigilance operations with a focus on regulatory compliance and vendor performance. The ideal candidate has a strong background in the pharmaceutical industry, with over 5 years of experience in drug safety operations and excellent leadership skills. This role offers the flexibility to work on-site or remotely, contributing to innovative solutions in the mental health space.

Qualifications

• 5+ years in Drug Safety / PV Operations within the pharma or biotech industry.
• In-depth knowledge of GCP, GVP, FDA, EMA, and ICH guidelines.
• Must be detail-oriented with strong organizational skills.

Responsibilities

• Lead the CRO transition management for pharmacovigilance operations.
• Oversee safety database migration and ensure regulatory compliance.
• Establish vendor governance mechanisms and monitor CRO performance.

Skills

Leadership skills

Communication skills

Adaptability

Problem-solving skills

Education

BS or advanced degree in life science, nursing, pharmacy, or healthcare

Tools

Oracle Argus safety database

Microsoft Office applications

Job description

A biopharmaceutical company is seeking an experienced Drug Safety / Pharmacovigilance Operations expert to lead the transition of pharmacovigilance operations with a focus on regulatory compliance and vendor performance. The ideal candidate has a strong background in the pharmaceutical industry, with over 5 years of experience in drug safety operations and excellent leadership skills. This role offers the flexibility to work on-site or remotely, contributing to innovative solutions in the mental health space.