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-specific requirements, and established timelines.

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

• Execute clinical and partner reconciliation.

• Manage personal data protection initiatives.

• Address Product Quality Complaints and collaborate with Quality Assurance.

• Engage with Medical Information.

• Carry out MedDRA and WHO coding.

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

• Oversee workflow and resource management.

• Assist in pharmacovigilance processes within PrimeVigilance and for clients.

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

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

• Serve as LCPPV for the designated country as per agreement with the line manager.

• Assume the PRLS role for the specified language as agreed upon with the line manager.

⛳️ Requirements

• Graduate in life sciences, pharmacy, nursing, or related healthcare qualification, or possess 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 skills, covering time and issue management.

• Proficient in English, both spoken and written, at an advanced level.

• Advanced proficiency in MS Office applications.

🏝️ Benefits

• Opportunity for remote work.

• Flexible work culture.

• Opportunities for professional growth.

• Collaborative and supportive team environment.

• Global work atmosphere.

• Inclusive and belonging culture.

• Chance to contribute to patient safety.

• Work alongside experts in clinical research, pharmacovigilance, and quality consulting.