A life sciences company in the area of Ghent is looking for new talent! They are hiring a Drug Safety Officer / Patient Safety Specialist.
- Are you a Medical Doctor or Pharmacist?
- Do you have preferably 1 year of experience in the Pharmaceutical industry?
- Are you fluent in English and one other European language?
Then this is your chance to start a great career in the life sciences industry! Call me or send your cv to firstname.lastname@example.org.
Your primary responsibility is to provide accurate and up to date medical responses to product enquiries from healthcare professionals and other customers in a professional, ethical, compliant and timely manner.
- Ensure that the company's medicines are used safely and effectively.
- Answer medical enquiries + tracking questions and answers
- Develop and update readily accessible bibliographies, standard response letters (SRLs) and frequently asked questions (FAQs) on major products while ensuring medical/scientific accuracy.
- Review provided local answers to medical enquiries in the different countries
- 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
- Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports
- Act as a significant point of contact between DSOs (Drug Safety Officers) on medical content and regulatory reporting of ICSRs
- Review and validation of signal relevant articles
- Investigate potential signals (literature, database, safety documents)
- Provide scientific review and interpretation of safety data for the preparation of aggregate reports including but not limited to Signal Evaluation Reports, PSURs, PSUR assessment report responses and RMPs.
- Assist in the medical review of aggregate safety documents (PBRER/PSUR and ACO)
- Review of Risk Management plans
- Provide expertise for all safety related medical tasks
- Assess safety information related to the preparation and revision of SmPCs.
- Conduct medical review and advise on responses to regulatory inquiries
- Available to support reconciliation activities as directed (e.g. for drug safety/product quality)
- You will collect the required data for the authoring of Safety documents.
- You will document, write, coordinate, review and validate periodic reports such as PBRER, RMP, ACO and other related safety documents.
- You ensure generation, consistency, and quality of safety sections in submission documents.
- You discuss the content and strategy of safety documents with important stakeholders within the Benefit/Risk Group and Global Regulatory Affairs.
- You participate on writing responses or contributions for the health authorities related safety enquiries.
- You work with a cross functional team to realize deadlines for health authority requests and submissions.
- Ensure that safety documents (e.g. periodic reports, signal evaluations, regulatory enquiries, risk management plans) are written accurately and in a timely manner to meet global compliance and regulatory requirements.
- Provide support for submission of PSUR’s
- Assist in creations of core structured benefit-risk assessments, core Risk Management Plans (RMPs), and EU RMPs.
- Supports development of risk management plans in modular format and cross-use and reference of modules in PBRER etc.
- Develops and maintains respective standards and calendars for PSURs
- Contributes to cross-functional initiatives aimed to improve pharmacovigilance capabilities related to benefit -risk management
- Supports inspection and audit activities with regards to the RM & BRE processes within Safety
- Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
- You will be safety responsible for the project of the implementation/development/update of CDS/CSI for the company's medicines portfolio
- You have experience in writing and management of CDS/CSI
- You manage cumulative safety planning in accordance with timelines as mentioned into signal management procedure.
- Management of the literature review process and make sure that it's continuously aligned with the corresponding SOP.
- Collection, management & control of countries Literature log
- Validate periodically the literature review criteria & key words provided by the service provider.
- Work very closely with the literature review service provider to improve if needed the process in place
- Ensure the systematic and continuous quality control/check of the literature review outputs
- A Medicine or pharmacist degree and/or you have 1 year of relevant experience in pharmacovigilance.
- Having a good knowledge of PSUR & RMP and being able to write safety documents is a real plus.
- You are a quick & reactive learner
- Highly analytical, process minded and detail oriented.
- Being able to work in a matrix environment whilst remaining organized at all times.
- Having a hands on-mentality and a proactive attitude.
- Being fluent in English and having excellent communication skills. Knowledge of other European languages is an asset.
- You are a true team player.
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