Job Description

Job Title: Pharmacovigilance Specialist

Location: Columbus, OH (Onsite, Full-time)

Contract Duration: Minimum 1-year contract

Start Date: ASAP

Job Overview:

We are seeking an experienced Pharmacovigilance (PV) Specialist to join our team. This role requires a strong background in pharmacovigilance, regulatory compliance, and medical writing. The successful candidate will participate in adverse event processing, literature reviews, periodic safety reports, and signal management activities while ensuring compliance with relevant global regulatory requirements. This is a long-term project offering flexible hours.

Key Responsibilities:

• Act as a subject matter expert (SME) in pharmacovigilance, demonstrating a high level of scientific and technical expertise.
• Ensure timely and compliant processing and reporting of adverse events associated with medical nutrition products registered as drugs.
• Maintain documentation and perform quality control checks related to adverse event reporting.
• Oversee and participate in global literature searches, handles processing and maintenance of safety related data found in literature.
• Conduct periodic safety reviews, signal management, and literature-based assessments for inclusion in safety reports.
• Prepare and review aggregate safety data, periodic safety update reports (PSURs), signal reports, and other pharmacovigilance-related documentation.
• Support the development and maintenance of product safety profiles and global pharmacovigilance processes aligned with best practices.
• Ensure compliance with worldwide pharmacovigilance regulations and guidelines.
• Develop an understanding of liquid nutrition and its role within the medical nutrition field.

Qualifications and Preferred Experience:

• Bachelor’s degree in a health science-related field required; Master’s degree preferred.
• Minimum of 5 years of experience in pharmacovigilance.
• Strong understanding of adverse event reporting, regulatory requirements, and safety data interpretation.
• Experience with medical writing, including the preparation of safety reports, medical assessments, and regulatory documents.
• Prior experience conducting global literature reviews and assessing safety data.
• Hands-on experience with pharmacovigilance regulations
• Exposure to signal management and periodic safety reviews.
• Strong analytical and problem-solving skills with a focus on quality and compliance.
• Ability to communicate scientific and medical data effectively both orally and in writing.
• Preference for candidates with broad pharmacovigilance experience beyond case processing.

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