...Biometrics you will manage a cross-functional team in the execution of the biometric and medical affairs (medical review and pharmacovigilance) aspects of a clinical trial. Your main responsibility is to plan, organize, coordinate and control the project-related biometric...
...review and approval of promotional activities and materials for multiple pharmaceutical companies in Benelux and contribute in pharmacovigilance projects.
Promotional material & activities:
Advice the Marketing departments of several MAHs in developing strong but...
P95 – Excellence in Pharmacovigilance & Epidemiology
P95 delivers cutting edge expertise in epidemiology and pharmacovigilance. We are passionate about healthcare and help our customers with innovative medical research. We share a sense of urgency with our customers to deliver timely, pragmatic and useful...
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical...
...in Medical Science
At least 5-7 years' experience in the pharmaceutical industry, with at least 4 years of it in medical writing
Experience in drug discovery and pharmacovigilance is desirable
fluent in English
...Managers, etc. are trained according to their respective functions
~Secure compliance and adheres to medico/legal/regulatory/pharmacovigilance/quality requirements through applying all laws, regulations, policies, SOPs and adheres to highest standards of ethics and integrity...
...across Data sources (One Key among others) - MDM - CRMxx, or, for the "pre-commercial" domain, the analysis of Clinical, R&D, pharmacovigilance data source that will feed a product MDM solution
Produce "data architectures"; you will analyze the data (profile the data...
...team is responsible for auditing all processes related to clinical research including specific medical affairs processes, and pharmacovigilance activities, to assess compliance with relevant regulations and applicable policies and procedures. This includes investigator...
...Leadership Team/s, Country Medical Council/s and other strategic teams in the vaccines area;
~Effectively collaborate with country Pharmacovigilance, research and regulatory teams and assist in managing the country commitments, all within relevant therapeutic area....
...support to the organization on thecontent of existing marketing authorizations and for products in
Support pharmacovigilance department on safety
relevant matters in line with national requirements
Follow-up with the
...Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.
If you would like to discuss this vacancy further, please...
...subject/patient’s safety and clinical data integrity at an
investigator/physician site such as protocol deviation/violations and
Per the Clinical
Monitoring/Site Management Plan (CMP/SMP):
Assesses site processes
Conducts Source Document...
...Escalate important issues as they arise to management colleagues and ensure adverse event and quality reporting, in compliance with Pharmacovigilance and Quality department guidelines.
Assure medical validity and provide input to the activities of Medical Safety Review Team...
...1993 laying down the conditions of supply of samples of medicinal products for human use;
Act as the Local contact person for pharmacovigilance (LCPV)
for the pharmaceutical products Iruxol Mono & Novuxol.
provide regulatory affairs (RA) and quality assurance (QA)...
...one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Covance has an FSP opportunity to match your area of expertise.
Each FSP offers a unique opportunity to be a part of the...
...Clinical Research Manager, Clinical Operations Manager, Medical Advisors; Medical Information team / specialists; affiliate pharmacovigilance / drug safety personnel, Marketing and Sales personnel for assigned product and therapeutic area; Affiliate Brand teams Leads...
...dossiers/data-packages in order to meet the submission timelines
You ensure that all regulatory aspects on the product safety/Pharmacovigilance and commitments/obligations to Authorities are closely monitored and fullfilled
You prepare cover letters, application forms,...
...GRA delegates and with GRA stakeholders that use the systems and processes (e.g., Affiliates, Clinical, Non-Clinical, Safety, Pharmacovigilance, Technical Operations, Partners).
~Ensuring the consistent use of submission standards, processes, and technologies globally...
Braine L'alleud, Walloon Brabant, Belgium
Drug Safety & Pharmacovigilance
Help us transform patients’ lives.
At UCB, we put our heart, soul and skills into making a...