Senior PV Associate

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Assist with various activities undertaken by the project team on behalf of both the client and the company.

• Execute tasks within the ICSR management unit, adhering to the established scope and timeframe.

• Process Individual Case Safety Reports (ICSRs) from all sources while ensuring compliance with relevant regulations, PrimeVigilance procedures, client expectations, and deadlines.

• Conduct ICSR follow-up, SAE/SUSAR management, unblinding, clinical trial reconciliation, protocol review, and Safety Management Plan review.

• Carry out clinical and partner reconciliation.

• Manage personal data protection and address Product Quality Complaints.

• Collaborate with Quality Assurance and Medical Information teams.

• Implement MedDRA and WHO coding.

• Generate database outputs and reports, including data for monthly client reporting.

• Assist with workflow and resource management.

• Contribute to pharmacovigilance processes for both PrimeVigilance and its clients.

• Provide support to the RA & PV Network Department as required.

• Serve as LCPPV for a designated country and PRLS for a specific language, as agreed upon with the line manager.

⛳️ Requirements

• A degree in life sciences, pharmacy, nursing, or another healthcare-related qualification, or relevant experience in pharmacovigilance.

• At least 1 year of experience in pharmacovigilance.

• Strong organizational skills, with a keen attention to detail and the ability to multitask.

• Effective management skills, including time and issue management capabilities.

• Proficiency in English at an advanced level (both spoken and written).

• Advanced proficiency in MS Office applications.

🏝️ Benefits

• Opportunities for training and career development within the organization.

• A strong focus on personal and professional growth.

• A friendly and supportive working environment.

• The chance to collaborate with colleagues from around the globe, with English as the primary language of communication.

• A commitment to equal opportunities in the workplace.

• A human-centric work environment.

• Support for employee experience, well-being, and mental health.

• A healthy work-life balance.