Global Pharmacovigilance Medical Safety Writer - Temporary

TL;DR

Global Pharmacovigilance Medical Safety Writer (Temporary): Process owner for developing pharmacovigilance documents including Periodic Safety Reports, Safety Strategy, and Core Benefit-Risk Documents with an accent on aggregates like PBRERs/PSURs, PADERs, RMPs, DSURs, and ACOs. Focus on writing, consolidating, submitting reports, leading cross-functional teams, ensuring compliance, and managing Health Authority interactions.

Location: Italy with possibility of smart working

Company

International research-focused biopharmaceutical group with 90 years’ experience, headquartered in Parma, Italy, operating in more than 30 countries.

What you will do

• Support global planning and lead writing, consolidating, updating, and distributing aggregate reports (PBRERs/PSURs, PADERs, RMPs, DSURs, ACOs) with cross-functional teams.
• Handle report submissions to Health Authorities, compliance monitoring, and QC for aggregates and planning.
• Manage Health Authorities’ assessments, support Safety Physicians on ACOs for product renewals, and calculate quality KPIs.
• Align risk management materials with approved documents and produce high-quality pharmacovigilance documents.
• Collaborate cross-functionally, upload documents to EDMS, monitor inboxes and HA websites, and represent in audits/inspections.
• Support QPO on compliance, SOPs, training, and service agreements.

Requirements

• Minimum 1 year of experience in pharmacovigilance (medical writing preferred), practical knowledge of drafting PSUR/PBRER, PADER, ACO, RMP, DSURs.
• Master’s degree in science, PhD or similar.
• English fluent.
• Capacity for in-depth data evaluation, data analysis, procedures writing, training, knowledge of domestic/international regulatory safety reporting.

Culture & Benefits

• Comprehensive healthcare programs, work-life balance initiatives, robust relocation support, tax assistance for foreign colleagues.
• Competitive salary with performance bonuses, flexible working arrangements, remote work options.
• Access to resources and training for development in a dynamic environment.
• Commitment to diversity, inclusion, sustainability as a Benefit Corporation and B Corp.