Senior Pharmacovigilance Associate

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

📋 Description

• Process Individual Case Safety Reports (ICSRs) from various sources while adhering to relevant regulations, PrimeVigilance procedures, and client-specific timelines.

• Conduct follow-ups on ICSR, which includes managing SAE/SUSAR, unblinding, reconciling clinical trials, reviewing protocols, and assessing the Safety Management Plan.

• Execute clinical and partner reconciliation activities.

• Ensure compliance with personal data protection regulations.

• Address Product Quality Complaints and collaborate with Quality Assurance teams.

• Engage with Medical Information departments.

• Perform MedDRA and WHO coding tasks.

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

• Oversee workflow and resource management.

• Assist in pharmacovigilance processes related to ICSR management for both PrimeVigilance and clients.

• Undertake tasks assigned under Standard Operating Procedures (SOPs) for junior roles.

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

• Serve as the Local Contact Person for Pharmacovigilance (LCPPV) for the designated country when appointed.

• Act as the Person Responsible for Local Screening (PRLS) for the specified language when designated.

⛳️ Requirements

• Bachelor's degree in life sciences, pharmacy, nursing, or another healthcare-related field, or relevant experience in pharmacovigilance.

• At least 1 year of professional experience in pharmacovigilance.

• Strong organizational skills, including attention to detail and the ability to multitask.

• Effective management abilities, encompassing time and issue management.

• Proficient in English, both spoken and written (advanced level).

• Advanced skills in MS Office applications.

🏝️ Benefits

• Option for remote work.

• Flexible work environment.

• Opportunities for professional growth.

• Collaborative team atmosphere.

• Diverse and inclusive workplace culture.

• Culture focused on belonging.

• Collaboration with global teams across Europe, North America, South America, Asia, and Australia.

• Chance to contribute to patient safety and pharmaceutical treatment.

• Join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.