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 procedures, client specifications, and deadlines.

• Conduct follow-up activities for ICSR.

• Oversee SAE/SUSAR tasks, which include unblinding, clinical trial reconciliation, protocol analysis, and Safety Management Plan evaluation.

• Execute clinical and partner reconciliation.

• Manage activities related to personal data protection.

• Address Product Quality Complaints and collaborate with Quality Assurance.

• Engage with Medical Information.

• Carry out MedDRA and WHO coding.

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

• Assist in workflow and resource management.

• Facilitate ICSR-related pharmacovigilance procedures for PrimeVigilance and its clients.

• Undertake tasks designated for more junior roles as required by a senior colleague.

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

• Serve as LCPPV for a specific country when assigned.

• Function as PRLS for a specified language when designated.

⛳️ Requirements

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

• At least 1 year of experience in pharmacovigilance.

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

• Proficient management skills, covering time and issue management.

• Advanced proficiency in spoken and written English.

• High level of literacy in MS Office applications.

🏝️ Benefits

• Option for remote work.

• Flexible working environment.

• Opportunities for professional growth.

• A collaborative and supportive team culture.

• A diverse and inclusive workplace.

• Chance to collaborate with global teams.

• Engaging work that contributes to patient safety.

• Exposure to the fields of clinical research, pharmacovigilance, and quality consulting.

• A passionate and cooperative team of experts.