Senior PV Associate

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

📋 Description

• Assisting with various activities carried out by the project team on behalf of both the client and the company.

• Executing tasks within the ICSR management unit according to the agreed scope and timeline.

• Managing the processing of Individual Case Safety Reports (ICSRs) from all sources, ensuring compliance with applicable regulations, PrimeVigilance procedures, and specific client requirements and deadlines.

• Conducting follow-ups for ICSR, including SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review).

• Performing reconciliation tasks (clinical and with partners).

• Ensuring personal data protection.

• Handling Product Quality Complaints and collaborating with Quality Assurance.

• Engaging in Medical Information interactions.

• Utilizing MedDRA and WHO coding standards.

• Generating Database Outputs and Reports, which include data for monthly client reporting.

• Managing workflows and resources.

• Supporting pharmacovigilance processes related to ICSR management within PrimeVigilance and for clients.

• Senior colleagues may undertake tasks designated by SOP for more junior positions.

• Providing assistance to the RA & PV Network Department as required, including serving as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and assuming the role of PRLS (Person Responsible for Local Screening) for the designated language, as coordinated with the line manager.

⛳️ Requirements

• A graduate in life sciences, pharmacy, nursing, or another healthcare-related field, or equivalent experience in pharmacovigilance.

• At least 1 year of professional experience in pharmacovigilance.

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

• Proficient management skills, including time and issue management.

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

• Advanced literacy in MS Office applications.

🏝️ Benefits

• Opportunities for training and career development within the organization.

• A strong focus on both personal and professional growth.

• A friendly and supportive working environment.

• The chance to collaborate with colleagues from around the world, using English as the company language.