Responsibilities

Acting as LRPPV in France and as single point of contact to French health authorities Answers to questions from authorities (national, European surveys, ad hoc answers) requiring medical analysis Exchange periodically with Marketing Authorization Holders regarding PV systems PSMF, SDEA writing, Production and validation of reports depending on seniority and after successful experience in writing Handling signal detection, Off label use reports and aggregate reports (DSUR, PSUR, RMP, ACP etc) Represents medical writing as part of a global, cross[1]functional team and work independently to successfully drive the production and development of each deliverable document following the client business process. Assists in the preparation of Standard Operating procedures (SOPs) and Working Practice Documents. Ensure adherence to GCP, ICH guidelines, SOPs, and client templates. Provide frequent and purposeful communication, ensuring all stakeholders are kept informed of progress and updates, as needed, in real-time CLIENT/EXTERNAL CONTACTS Prepares, reviews and provide feed-back for safety reports including: Development Safety Update Reports (DSURs), Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports (PSURs/PBRERs) ,Risk Management Plans (RMPs), Addendum to Clinical Overviews (ACOs) Understands and interprets clinical and scientific reports to allow the accurate capture of safety and efficacy data. Interprets and presents scientific data, analyses and appraise clinical, biomedical and scientific reports in a systematic, accurate, fair and balanced way. Analyses clinical evidence of all kinds (public, proprietary, published, or unpublished, etc.) from all sources (journals, internal documents, regulatory submissions, etc.) in order to assist customers, colleagues and management. Understands levels of evidence required to achieve regulatory and goals. Prepares and review the aggregate reports Conducts comprehensive literature searches to support research, clinical evidence, product development, risk analysis, regulatory submissions. Writes ad hoc reports based on these literature searches. Identify suspected spontaneous adverse drug reaction reports from the information given by customers during enquiry handling and ensure they are accurately reported to the appropriate Pharmacovigilance LOB in line with legal and company requirements Provides timely, accurate, appropriate and clear verbal and written information in response to enquiries about PLG customers’ products or therapy areas in order to facilitate the appropriate, effective, safe and continued use of company product QUALITY/SYSTEM MANAGEMENT Supports other Medical Writer and the Activity manager in reviews metrics to assess accuracy, quality and regulatory compliance of MI VI outputs. Participates in training as required for ProductLife Group. Complies with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives.

Education & Experience

Pharmacist or medical degree Minimum 4 years experience in PV operational activities Experience in preparation of signal and aggregate reports (PSUR, DSUR etc.) BPPV France/GVP Knowledge of case management at least

Skills

Database experience preferred Knowledge of current regulations Process oriented Rigorous and ability to work in a team Use of Microsoft Office tools Ability to multitask Flexibility Excellent communication skills in French and in English for business continuity

Publish Date

12 August, 2024

Spontaneous Application

Medical Writer LRPPV 314

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