Senior Pharmacovigilance Associate

This is a fully remote position, open to applicants in New Zealand, +1 more country.

📋 Description

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

• Conduct follow-up activities for ICSR.

• Oversee SAE/SUSAR activities, which include unblinding, clinical trial reconciliation, protocol review, and Safety Management Plan assessment.

• Execute clinical and partner reconciliations.

• Manage personal data protection tasks.

• Address Product Quality Complaints and liaise with Quality Assurance.

• Collaborate with Medical Information.

• Perform MedDRA and WHO coding.

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

• Administer workflow and resource allocation.

• Assist in pharmacovigilance processes for PrimeVigilance and its clients.

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

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

• Act as LCPPV for a specific country and PRLS for a designated language, as coordinated 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 pharmacovigilance.

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

• Management capabilities, encompassing time and issue management.

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

• High-level literacy in MS Office applications.

🏝️ Benefits

• Option for remote work.

• Flexible working environment.

• Opportunities for professional growth.

• A collaborative and supportive team culture.

• Global outreach and an international work setting.

• A workplace focused on a sense of belonging.

• Chance to contribute to patient safety and improve pharmaceutical treatment outcomes.