Senior PV Officer

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

📋 Description

• Offer assistance to project teams for client and company activities.

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

• Conduct follow-up on ICSR, including management of SAE/SUSAR, unblinding, clinical trial reconciliation, protocol assessment, and review of Safety Management Plans.

• Execute clinical and partner reconciliation tasks.

• Oversee activities related to personal data protection.

• Manage Product Quality Complaints and liaise with the Quality Assurance team.

• Collaborate with Medical Information teams.

• Conduct MedDRA and WHO coding.

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

• Supervise workflow and resource allocation.

• Mentor and provide training to new and junior staff members.

• Assist in pharmacovigilance processes for PrimeVigilance and its clients.

• Serve as an ICSR Subject Matter Expert when required.

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

• Act as the Local Contact Person for Pharmacovigilance (LCPPV) for a specific country and Person Responsible for Local Screening (PRLS) for a designated language, as agreed upon with the line manager.

⛳️ Requirements

• Graduate in life sciences, pharmacy, nursing, or another healthcare-related field, or possess relevant experience in pharmacovigilance.

• 10–12 years of professional experience in pharmacovigilance.

• Strong written and verbal communication abilities.

• Excellent organizational skills, with a focus on attention to detail and the ability to multitask.

• Proficiency in delegation.

• Effective planning and time management skills.

• Technical proficiency.

• Ability to work collaboratively in a team.

• Fluent in spoken and written English.

• Advanced skills in MS Office applications.

🏝️ Benefits

• Option for remote work.

• A collaborative and supportive team atmosphere.

• Flexible work culture.

• Opportunities for professional growth.

• An inclusive workplace culture that fosters a sense of belonging.

• A dedicated team of experts in clinical research, pharmacovigilance, and quality consulting.