Senior Pharmacovigilance Associate

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

📋 Description

• Processing Individual Case Safety Reports (ICSRs) from various sources while adhering to relevant regulations.

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

• Engaging in reconciliation activities (clinical and partner-related).

• Ensuring the protection of personal data.

• Managing Product Quality Complaints and collaborating with Quality Assurance.

• Interacting with Medical Information.

• Performing MedDRA and WHO coding.

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

• Overseeing workflow and resource management.

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

⛳️ Requirements

• A graduate in life sciences, pharmacy, nursing, or other health-related fields, or demonstrated experience in pharmacovigilance.

• At least 1 year of experience in the field of pharmacovigilance.

• Strong organizational abilities, with a keen eye for detail and the capacity to multitask.

• Effective management skills encompassing time and issue resolution.

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

• High level of competency in MS Office applications.

🏝️ Benefits

• Opportunities for training and career development within the organization.

• A strong focus on both personal and professional development.

• A friendly and supportive working environment.

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