- Detect the combinations of questions & answers which could trigger a PV event to report in the studies.
- Evaluate the pharmacovigilance risk of the questionnaires administered to respondents (healthcare professional, patients...).
- Assess studies feasibility in terms of PV reporting.
- Participate in organizing and providing PV trainings to internal and external stakeholders.
- Implementing pharmacovigilance reporting process for studies.
- Writing of instructions to interviewers/moderators to ensure correct events are reported within the timelines.
- Ensure follow-up information requests (from the MAH) are fulfilled.
- Test automated systems to identify AEs/PV data generated from the online studies (ensure events are correctly spotted).
- Know and maintain the workflow and deadlines for each project.
- Review of notebooks received daily to detect potential adverse events.
- Filling in and sending adverse event forms to meet deadline and in accordance with legal requirements.
- Perform and coordinate reconciliation and source data PV verification.
- Ensure the filing and archiving of files in accordance with local, global, and European regulations for the pharmacovigilance requirements.
- Create and maintain dashboards.
- Maintain standard procedures for ongoing activities.
- Actively participate to the client audits.
- Ability to identify and author CAPA.
- Candidate will not perform signal detection, aggregate reports writing, and will not enter enter ICSRs into safety database.
- Pharmacy degree, Pharm. D.
- Minimum of 1 year of experience in Pharmacovigilance;
- Fluency in English and French (C1); both will be used on a daily basis;
- Excellent communication skills – able to distill issues, manage client expectations and act as a trusted advisor in a timely manner;
- Ability to multitask and work under-pressure with tight deadlines;
- Ability to prioritize;
- Excellent organization skills and attention to detail;
- Excellent IT skills (Pack Office).
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Drug Safety Officer - Colombes, France - Oracle
Description
Our health colleagues help life sciences companies develop products that improve people's lives and well-being. Their blend of consulting, data analytics, and real-world research and evidence enables clients to understand patients, physicians and payers, bring products to market quickly, navigate the regulatory pathway and negotiate payer reimbursement and coverage.
Oracle Life Sciences is the world's leading data, insights and consulting company. We understand more about how people think, feel, shop, share, vote and view than anyone else. Combining our expertise in human understanding with advanced technologies, Oracle Life Sciences' 30,000 people help the world's leading organizations succeed and grow.
KEY OUTCOMES
CAPABILITIES
Career Level -
Performs evaluation of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and suggests recommendations for changes. Conducts and facilitates internal and external audits to identify, evaluate, disclose and appropriately remedy risks and deficiencies with some guidance based on complexity. Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company as well as for internal and external audits and inspections. Respond to security related requests and RFPs . Update and maintain internal and externally facing security documentation. Facilitate 3rd party audit activities. Maintain and track required security training for the GBUS. Maintain and update security and compliance reporting. Facilitate vendor security assessments as needed. Assist in managing security and compliance related projects for the GBUs.
