Aktuelle Jobs im Zusammenhang mit Local Contact Person for Pharmacovigilance and Regulatory Affairs - Frankfurt - PrimeVigilance
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Frankfurt am Main, Hessen, Deutschland PrimeVigilance Vollzeit 80.000 € - 120.000 € pro JahrCompany DescriptionPrimeVigilance (part of Ergomed Group), is a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and...
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Pharmacovigilance Regulatory Affairs Specialist
vor 1 Woche
Frankfurt am Main, Deutschland PrimeVigilance VollzeitCompany Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...
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Pharmacovigilance Specialist
Vor 3 Tagen
Frankfurt am Main, Deutschland Syneos Health Clinical Vollzeit**Overview** **Base location: Neu-Isenburg** **Regions covered: Germany** The Global Safety Regions Specialist (GSRS) will follow the strategic direction for Global Safety Regions while establishing and maintaining it globally. The GSRS will also maintain the locally needed standardised practices to ensure compliance with international and national...
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Head of Regulatory Affairs Systems Business Support
vor 2 Wochen
Frankfurt Am Main, Deutschland BI Vetmedica GmbH Vollzeit**THE POSITION**: In our Boehringer Ingelheim Animal Health Business Unit (BI AH), the Regulatory Affairs & Pharmacovigilance team within Global Innovation enhances business value along the complete life-cycle of veterinary medicines. This starts with research and product development, continues with quality and timely regulatory submissions and approvals in...
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Pharmaceutical Regulatory and Compliance Legal
Vor 3 Tagen
Frankfurt am Main, Deutschland Axiom Talent Platform VollzeitWe are currently seeking a Pharmaceutical Regulatory and Compliance Legal Counsel (M/F/d) to work with a our client, a F100 technology company] in-house. This is an exciting opportunity where you can bring your legal background and business acumen to work on cutting-edge while tackling complex legal challenges on a global scale. This opportunity enables you...
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Analyst for Regulatory Affairs
vor 1 Tag
Frankfurt am Main, Hessen, Deutschland Deutsche Börse Vollzeit 50.000 € - 80.000 € pro JahrBuild the future of financial markets. Build yours.Ready to make a real impact in the financial industry? At Deutsche Börse Group, we'll empower you to grow your career in a supportive and inclusive environment. With our unique business model, driven by 15,000 colleagues around the globe, we actively shape the future of financial markets. Join our One...
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Analyst for Regulatory Affairs
vor 1 Tag
Frankfurt am Main, Hessen, Deutschland Deutsche Börse Group Vollzeit 60.000 € - 120.000 € pro JahrYour area of work: You are passionate about financial markets and keen on driving the regulatory strategy of one of the globally leading financial market infrastructure providers? Group Regulatory Strategy (GRS) is responsible for monitoring and analyzing political and regulatory initiatives, for positioning Deutsche Börse Group (DBG) towards political and...
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Analyst for Regulatory Affairs
vor 22 Stunden
Frankfurt am Main, Hessen, Deutschland Deutsche Börse Group Vollzeit 55.000 € - 85.000 € pro JahrYour career at Deutsche Börse GroupYour area of work:You are passionate about financial markets and keen on driving the regulatory strategy of one of the globally leading financial market infrastructure providers? Group Regulatory Strategy (GRS) is responsible for monitoring and analyzing political and regulatory initiatives, for positioning Deutsche Börse...
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Manager, Regulatory Affairs
vor 2 Wochen
Frankfurt am Main, Deutschland Alimentiv VollzeitManager, Regulatory Affairs (Europe)Management of Regulatory Affairs personnel through line management and project delivery oversight. Responsible for developing study regulatory strategies and leading department initiatives. The role involves collaboration with other departments to support the successful approval of clinical trials. May have...
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Executive Vice President, Pharmacovigilance Operations
vor 24 Stunden
Frankfurt am Main, Hessen, Deutschland Ergomed VollzeitCompany Description We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...
Local Contact Person for Pharmacovigilance and Regulatory Affairs
vor 2 Wochen
Job DescriptionThe Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) serves as the primary local representative to ensure compliance with national pharmacovigilance and regulatory requirements. This dual-role position is responsible for executing PV and RA activities at the local level, supporting the Marketing Authorisation Holder (MAH) in maintaining product compliance throughout its lifecycle.Main responsibilitiesPrimary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance as per local requirementsPrompt and effective communication with local regulatory authoritiesProvision of local regulatory intelligence screening and expert adviceCollection and reporting of locally suspected ADRs or ICSRs (FUs, translations)Local management / oversight of risk minimization measures related to urgent safety restrictions and emerging safety issuesPreparation and collection of documentation for submissions to the regulatory authoritiesReview and linguistic input on local Product Information and Mock-ups Development and implementation of local pharmacovigilance system in compliance with Global MAH's system and local regulationsPerform local non-indexed literature screening and screening of regulatory authority website/s for potential Adverse Drug Reactions (ADRs) and safety informationMaintain accurate records and documentation at local levelProvide support to the RA & PV Global operations teamEnsure compliance with MAH's and PrimeVigilance's proceduresSupport audits and InspectionsHandle local QA tasks such as suspected falsified products, quality alerts received from health authorities and other quality-related requirements received from the local marketQualificationsBachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experienceMinimum 3 years within pharmaceutical or CRO industry or regulatory authorityMinimum 2 years within LCPPV role, or relevant pharmacovigilance experience in safety-related positionPharmacovigilance training and/or working experience and other educational or professional background as required by local regulationsPrior experience in Regulatory Affairs is preferred but not mandatoryExpert knowledge of ICH GVP and relevant local legislation/ regulatory requirements in territories of competencyProficiency in English and German, both written and verbalStrong skills in Microsoft Office applications, including Word, Excel, and PowerPointAdditional InformationWhy PrimeVigilanceWe prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. We offer: Training and career development opportunities internally Strong emphasis on personal and professional growth Friendly, supportive working environment Opportunity to work with colleagues based all over the world, with English as the company language Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships We look forward to welcoming your application. #LI remote
