GPV Medical Safety Writer

Purpose

Process owner (cross-functional) for developing a wide range of pharmacovigilance documents for the assigned global products within the specific therapeutic area, including but not limited to Periodic Safety Reports, Safety Strategy and Core Benefit-Risk Documents.

Main Responsibilities

Aggregates (PBRERs, PADERs, DSURs, ACOs)
•    To support the Coordinator in the 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 the 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 the 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;

Risk Management Materials
•    To support TA Physicians in aligning risk management materials with the current approved documents including PBRER, ACO, PADER, RMP, presentations, and signal evaluations; 

General
•    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.

Experience Required

Minimum 1 year of experience in pharmacovigilance (medical writing experience is preferred), with theoretical and/or practical knowledge of PSUR/PBRER, ACO, RMP and DSURs.

Education

Master’s degree in science, PhD or similar preferred

Languages

English fluent

Technical Skills

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

Soft Skills