Pharmacovigilance Specialist

Job Title: Data Information Manager

The role of a data information manager involves handling safety case receipt, data entry, quality control, and ICSR follow-up for clients. This position requires working in the Easter USA Time Zone and ensuring that all safety information received is properly processed and tracked.

Responsibilities:

• Perform local safety case receipt, processing, and data entry, with quality control tracking and ICSR follow-up of all safety information received for PLG clients.
• Manage generic or client-specific email boxes as required.
• Register, triage, assign, and coordinate vigilance cases for processing.
• Follow up requests with local reporters.
• Respond to queries from clients and reporters.
• Conduct periodic reconciliations to confirm proper handling of vigilance reports for PLG Clients.
• Support local pharmacovigilance activities as needed.
• Participate in audits and resulting action plans.

Requirements:

• Bachelor's or Master's degree in Medicine, Pharmacy, nursing, or a science-related field, or equivalent experience.
• 2+ years' experience in pharmacovigilance, including data entry and QC of cases.
• Previous experience working under deadlines.
• Strong understanding of US and EU PV regulations and pharmaceutical backgrounds.
• Deep knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment.

Skills and Qualifications:

• Excellent organizational and interpersonal skills.
• Ability to work well within a team.
• Excellent time management skills.
• Accountability and autonomy with assigned tasks.
• Process-oriented with good attention to detail.
• Effective communication skills, both written and verbal.
• Flexibility and adaptability to handle dynamic workloads.
• Works well under pressure and meets deadlines.
• Safety database experience.

Benefits:

As a data information manager, you will have the opportunity to work in a fast-paced environment and contribute to the success of our team.

What We Offer:

• A competitive salary and benefits package.
• Ongoing training and development opportunities.
• A collaborative and supportive work environment.
• The chance to work on challenging projects and develop your skills.