Senior Pharmacovigilance Associate

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

📋 Description

• Manage the processing of Individual Case Safety Reports (ICSRs) from all sources, ensuring adherence to relevant regulations, PrimeVigilance procedures, client specifications, and deadlines.

• Carry out follow-up activities for ICSR.

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

• Conduct reconciliations with clinical partners.

• Address personal data protection responsibilities.

• Manage Product Quality Complaints and liaise with Quality Assurance.

• Collaborate with Medical Information.

• Execute MedDRA and WHO coding.

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

• Oversee workflow and resource allocation.

• Assist in pharmacovigilance processes pertinent to ICSR management within PrimeVigilance and for clients.

• Undertake tasks typically assigned to junior roles, as appropriate for a more senior colleague.

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

• Serve as Local Contact Person for Pharmacovigilance (LCPPV) for the designated country and as Person Responsible for Local Screening (PRLS) for the assigned language, per agreement with the line manager.

⛳️ Requirements

• Degree 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 skills, with a focus on detail and the ability to multitask.

• Management skills, including effective time and issue management.

• Proficient in English, both spoken and written.

• Advanced proficiency in MS Office applications.

• Capability to serve as the LCPPV (Local Contact Person for Pharmacovigilance) for the designated country, as per agreement with the line manager.

• Ability to assume the role of PRLS (Person Responsible for Local Screening) for the assigned language, as agreed with the line manager.

🏝️ Benefits

• Option for remote work.

• Flexible working environment.

• Opportunities for professional growth.

• A collaborative team atmosphere.

• A culture of belonging and inclusivity.

• Chance to engage in global pharmacovigilance projects.

• Professional development by collaborating with experts in clinical research, pharmacovigilance, and quality consulting.