Medical Writer LRPPV 314
il y a 1 semaine
ProductLife Group is looking for a Medical Writer and LRPPV France to join our dynamic team to contribute to the activities performed in the Hub:
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Analyses clinical evidence of all kinds (public, proprietary, published, or unpublished, etc.)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
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