Role Overview

Process owner (cross-functional) for developing a wide range of pharmacovigilance documents for the assigned global products within the specific therapeutic area, including Periodic Safety Reports, Safety Strategy and Core Benefit-Risk Documents
To support the Coordinator in global planning (for both molecules under development and those with a Marketing Authorisation)
To be responsible for writing, consolidating, updating and distributing aggregates for global products with the cross-functional team
To be responsible for aggregates report submission to Health Authorities where applicable
To be responsible for compliance monitoring both for PSURs/PBRERs and DSURs submitted for global products/ molecules under development
To be QC Responsible for aggregate reports and global planning
To lead the process/project for cross-functional working teams
To manage related Health Authorities’ assessments (i.e., “requests for supplementary information -RSI)
To support Safety Physicians in writing the relevant sections of the documents for the Company products’ renewals in Addendum to the clinical overviews (ACOs) for global products and provide necessary support in case of RSI during the renewal procedure
To support/act as QC responsible the Coordinator in the calculation of quality Aggregate KPIs
To support TA Physicians in aligning risk management materials with the current approved documents including PBRER, ACO, PADER, RMP, presentations, and signal evaluations
To produce high-quality, accurate and fit-for-purpose documents with clear conclusions
To effectively and clearly communicate technical, medical, and scientific information in critical submission and internal PV documents to deliver high-quality reports within the specified timelines
To collaborate cross-functionally for continuous improvement of standards and best practices for medical writing
To upload pharmacovigilance documents for global products in the EDMS through the appropriate workflows
To monitor aggregates inbox and HA websites including CTIS for aggregate management purposes (e.g. EURD list, ASR RFI) and share the results with relevant stakeholders
To be the representative for MSW part in audits and inspections
To support QPO in compliance calculations related to PSURs/PBRERs and DSURs submission and to update the Regulatory Information Management System with PSURs/PBRERs submission in scope
To support QPO for SOPs and other controlled documents including Working Instruction and related training
To support QPO for service agreement preparation concerning aggregates

Requirements

Minimum 1 year of experience in pharmacovigilance (medical writing experience preferred)
practical knowledge of drafting PSUR/PBRER, PADER, ACO, RMP and DSURs
Master’s degree in science, PhD or similar
English fluent
Capacity to work on situations or data requiring an in-depth evaluation of various factors: Data analysis
Previous medical writing experience
Procedures writing and training performance
Knowledge of domestic and international regulatory safety reporting requirements

Benefits

comprehensive healthcare programs
work-life balance initiatives
robust relocation support
competitive salary package
performance bonuses
flexible working arrangements
remote work options
tax assistance services for foreign colleagues

Global Pharmacovigilance Medical Safety Writer

Key skills

About this role

Role Overview

Requirements

Benefits