Senior Pharmacovigilance Associate

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

📋 Description

• Process Individual Case Safety Reports (ICSRs) from various sources in accordance with relevant regulations, PrimeVigilance procedures, client specifications, and deadlines.

• Conduct follow-up activities for ICSR.

• Oversee Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including unblinding, clinical trial reconciliation, protocol assessment, and Safety Management Plan evaluation.

• Facilitate clinical and partner reconciliation.

• Manage activities related to personal data protection.

• Address Product Quality Complaints while collaborating with Quality Assurance.

• Engage with Medical Information.

• Execute MedDRA and WHO coding.

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

• Organize workflow and resources effectively.

• Assist in pharmacovigilance processes for both PrimeVigilance and its clients.

• Undertake tasks typically assigned to junior roles as appropriate for a senior position.

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

• Serve as the Local Contact Person for Pharmacovigilance (LCPPV) for the designated country and as the Pharmacovigilance Responsible Leader (PRLS) for the specified language, as agreed upon with the line manager.

⛳️ Requirements

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

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

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

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

• Proficient spoken and written English.

• Advanced proficiency in MS Office applications.

🏝️ Benefits

• Option for remote work.

• Flexible working environment.

• Opportunities for growth and advancement.

• Supportive and collaborative team culture.

• Inclusive and welcoming workplace.

• Chance to engage in global pharmacovigilance projects.

• Opportunity to contribute to patient safety through meaningful work.