Pharmacovigilance Case Specialist Hiring at ProductLife Group

Join ProductLife Group as a Pharmacovigilance Case Specialist

Are you an experienced professional in pharmacovigilance? ProductLife Group is hiring a Pharmacovigilance Case Specialist to join its team and contribute to the safety and regulatory compliance of pharmaceutical products. If you have a background in drug safety and regulatory affairs, this opportunity is for you!

About ProductLife Group

ProductLife Group is a global leader in regulatory compliance, pharmacovigilance, and quality assurance services. With a commitment to patient safety and regulatory excellence, the company provides comprehensive support to pharmaceutical and healthcare organizations worldwide.

Job Responsibilities

As a Pharmacovigilance Case Specialist, your key responsibilities will include:

• Quality Control of Vigilance Cases: Ensuring the accuracy and integrity of pharmacovigilance case data.
• Medical Evaluation of Reports: Reviewing and analyzing adverse event reports for compliance with regulatory standards.
• Data Entry & Case Processing: Entering vigilance case information into designated safety databases.
• Follow-up Requests: Engaging with healthcare professionals and patients to gather additional safety data.
• Causal Relationship Assessment: Assessing the link between adverse effects and suspect products.
• Regulatory Compliance: Ensuring adherence to FDA, GVP, and GCP guidelines for drug safety reporting.
• Medical Information Support: Responding to safety-related queries and providing expert insights.
• Quality Documentation: Assisting in the preparation and maintenance of regulatory and safety documentation.

Required Qualifications & Experience

To be considered for this role, candidates should meet the following criteria:

• Education: Doctor of Pharmacy (PharmD) or Medical Doctor (MD) degree.
• Experience: 3-4 years in pharmacovigilance or a related field.
• Technical Skills: Knowledge of pharmacovigilance databases (e.g., Argus, Safety Easy) and adverse event reporting.
• Regulatory Knowledge: Strong understanding of GVP, FDA, and global drug safety regulations.
• Soft Skills: Excellent communication, attention to detail, and ability to work in a team.
• Software Proficiency: Familiarity with Microsoft Office tools and database management.

How to Apply?

If you meet the qualifications and are ready to advance your career in pharmacovigilance, apply today! Send your application Via Linkedin

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