Drug Safety Associate/Senior Drug Safety Associate
Entry (0-2 ani), Middle (2-5 ani), Senior (5-10 ani)
ProductLife Group is looking for a Drug Safety Associate/Senior Drug Safety Associate in Cluj-Napoca!
ProductLife Group is the European industry-leading specialist service provider for the Life Sciences industry, focused on delivering high quality professional services in the areas of Regulatory, Safety, Quality, Process alignment and Medical services. All ProductLife Group’s services are targeting support for comprehensive compliance and safety throughout the product life cycle, therefore enabling continuity and productivity of product development and subsequent
As a result of an increase in workload we are now seeking a Drug Safety Associate/Senior Drug Safety Associate responsible for contributing to pharmacovigilance activities and medical information services performed on the PV Platform which includes pre and post marketing activities and interaction with health authorities on behalf of ProductLife customers.
We are looking for someone with excellent organisational and interpersonal skills, with ability to work and interact smoothly within an international team. For this role we are seeking a professional with excellent communication skills in English.
- Contribute to pharmacovigilance activities performed on the PV Platform. Pharmacovigilance activities include pre-marketing activities, post marketing activities and interaction with health authorities on behalf of ProductLife’ s customers.
- Contribute to the production of client administrative documents to be included in regulatory submissions.
- Undertaking data entry and document management for Pharmacovigilance (PV) aspects of allocated studies.
- Understanding and interpreting clinical and scientific reports which allows the accurate capture of safety data.
- Responsible for the triage, case processing and document management of safety documentation. Safety information to manage includes Adverse Events (AEs), Serious Adverse Event (SAE) reports from clinical trials, spontaneous reports, health authority reports and literature reports.
- Managing the safety mailbox and ensuring that case timelines are accurately assessed and recorded for continued compliance.
- Liaising with health care professionals (HCP) & Study investigators to collect follow up information.
- Assist the Drug Safety Specialists, Drug Safety Officers and other project staff with PVG project related tasks as required.
- Assist in the preparation of Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs).
- Assist in the management of ProductLife’s Quality Management System.
- Performing literature searches and review the outputs to assess the relevance of the articles prior to medical review.
- Undertake medical information services, which would include direct communication with healthcare professionals/consumers/any other reporters regarding queries or safety information relating to individual client products.
- Bachelor’s or higher graduate degree in a science related field or equivalent experience Is preferred;
- Minimum 1 year of experience in a similar position/pharmaceutical industry preferred;
- Good understanding of safety database software and MS Office;
- Effective oral and written communication skills in English;
- Good computer skills and the ability to learn appropriate software;
- Excellent organisational and time management skills;
- Ability to make informed decisions;
- Process orientated with good attention to detail;
- Excellent interpersonal skills;
- Ability to work well within a team.
- Fluent in English (spoken and written) for daily contacts with local and internationally project stakeholders.
- Full training on the job and external courses will be provided;
- Competitive salary package;
- Dynamic environment;
- International and growing company;
- Health insurance;
- Meal tickets.