Medical Writer LRPPV 314

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:

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Analyses clinical evidence of all kinds (public, proprietary, published, or unpublished, etc.)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.

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