Global Safety Expert (m/w/d) | Pharma | BaWüFür die Unterstützung des Teams sucht der exklusive Kunde einen engagierten Pharmakovigilanz-Experten (m/w/d). In dieser Rolle übernehmen Sie die globale Pharmakovigilanz-Produktverantwortung für die zugewiesenen Arzneimittel.Ihre Aufgaben:Überwachung des Nutzen-Risiko-Profils und Signal ManagementDurchführung von Risikomanagement-Aktivitäten, einschließlich der Erstellung von Risk Management Plänen sowie der Betreuung von RisikominimierungsmaßnahmenErstellung periodischer SicherheitsberichteBetreuung von interventionellen und nicht-interventionellen Studien sowie weiterer Datenerhebungsaktivitäten, einschließlich der Erstellung und Überprüfung studienspezifischer DokumenteUnterstützung bei der Erfüllung der Pharmakovigilanz-Verpflichtungen, insbesondere:Sammlung, Dokumentation und Bewertung von Arzneimittelrisiken, wie unerwünschte Arzneimittelwirkungen, Wechselwirkungen und GegenanzeigenMedizinische und wissenschaftliche Bewertung von Risiken und deren Dokumentation unter Berücksichtigung gesetzlicher MeldepflichtenWeitergabe relevanter Informationen an Pharmakovigilanz-Abteilungen bei Dienstleistern, Lizenznehmern, Vertriebspartnern und TochtergesellschaftenUnterstützung bei der Erstellung von Pharmakovigilanzverträgen sowie bei GVP-Inspektionen und AuditsErstellung und Pflege der Pharmakovigilanz-Stammdokumentation (PSMF) sowie von Standard-Arbeitsanweisungen (SOPs)Schulung von Mitarbeitenden und Partnern im Bereich PharmakovigilanzManagement der Fallbearbeitung und Literatursuche sowie Pflege der Pharmakovigilanz-DatenbankIhr Profil:Erfolgreich abgeschlossenes Studium der HumanmedizinFundierte Berufserfahrung im Bereich PharmakovigilanzAusgeprägte Teamfähigkeit und KommunikationsstärkeSehr sorgfältige und genaue Arbeitsweise sowie hohe ZuverlässigkeitSehr gute Deutsch- und Englischkenntnisse in Wort und Schrift Das bietet der Kunde:Eine spannende und verantwortungsvolle Tätigkeit in einem dynamischen UmfeldEin motiviertes und kollegiales TeamMöglichkeit zur fachlichen und persönlichen Weiterentwicklung Weitere Vorgehensweise: Sie interessieren sich für diese Position? Dann schicken Sie mir gerne Ihren aktuellen Lebenslauf zu und ich vereinbaren ein erstes Gespräch mit Ihnen.E-Mail: M.Inderhees@sciproglobal.deTel: 08926200925Ich freue mich auf Ihre Bewerbung!

SciPro is working on a search for a Director, Biostatistics for a unique Biotech we're incredibly excited to be taking to market and have worked with previously. They're a new kind of therapeutics company existing at the intersection of ML, biological engineering, and medicine to create breakthrough medicines. They have a proprietary platform that can generate medicines on demand across multiple therapeutic modalities with unprecedented speed and success rates, representing a fundamental shift in drug discovery. They've always been at the forefront of integrating GenAI/ML in drug discovery and this opportunity offers the ability to get as close as it gets to creating a therapeutic. They currently have 18 programs, 2 of them have been filed and financially they have raised over $700m over their 4 years of their existence, with their last Series C funding nearly at $280m. In this role you will report to the Head of Biometrics and is a new role within the Biometrics group. You will be successful in this role should you have the following qualifications: Industry experience (Pharma & Biotech preferred) with 8+ years' experience (PhD) or 10+ years' experience (Masters)Need this candidate to still be hands-on, strong R skills (SAS is ok)Thorough understanding of what end points are needed, SAPs, and ideally Phase II/III designEarly phase experience, ideally experienced with translational biostatisticsAbility to act independently and explain statistical concepts to cross-functional groupsIt's important the candidate understands overall clinical study programsHigh EQExcellent communication and human skillsCompetencies: rigorous, accountable, ability to work in a small company and step up/take ownership and a strong team player You will have high visibility into the work of cross-functional teams, senior leadership discussions on the company's direction, programs and strategy. They have tripled in size in the past 2 years and with no signs of slowing down, and are looking for an entrepreneurial Biostatistician to join their collaborative and ambitious team!

This ground-breaking biotech that is dedicated to the advancement of RNA therapies targeting chronic liver diseases is actively seeking a Senior Scientist to join their team. This company employs a blend of genomic deep phenotyping, precision RNA medicine, and experimentation utilizing live human donor livers to address significant challenges in liver health, including augmenting donor liver availability and mitigating complications arising from cirrhosis.This company is headquartered out of the UK but has a flagship location in New York City and this role will report directly into the Head of the R&D site. Responsibilities:Drive innovation through the development and implementation of cutting-edge phenotyping strategies, in-vitro assay development, and molecular and cellular biology techniques.Spearhead the design and execution of experimental plans, actively engaging in perfusion workflows.Analyze, evaluate, and interpret data and results derived from experiments.Foster active collaboration and communication with international team members.Qualifications:PhD in Life Sciences/Bioscience with 2-3 years of experience.Proficient in conducting laboratory assays including qPCR, western blots, immunofluorescence, cell-based assays, and flow cytometry.Skilled in handling omics technologies such as proteomics, metabolomics, and transcriptomics.Experienced in histology, including sample preparation and basic image analysis.Disease biology expertise with liver biology is preferred.

SciPro is partnered with an innovative drug discovery biotech in the NYC area. The person selected will serve as a key leader managing CRO's & consultants on toxicology studies for various modalities. Responsibilities:Provide leadership on toxicology programs from discovery to clinical developmentDesign & develop in vivo/in vitro toxicity studiesOversee pre-clinical studies at CROManage CRO teams and consultants Qualifications:PhD & 8 + years of industry experienceExperience working in or managing CRO'sExperience working on biologics & small molecule toxicology programsIND filing experience All interested applicants are encouraged to apply below.

SciPro has partnered with a leading pharmaceutical organization that is seeking an experienced scientist to lead ADME efforts within a multidisciplinary team. This role focuses on advancing drug discovery and development through experimental design, data interpretation, and collaboration across various functions, contributing to regulatory submissions and therapeutic innovations. Key Responsibilities:Deliver integrated data packages for compound selection, study design, and regulatory submissions.Collaborate across Discovery and Development teams to optimize ADME properties and advance drug candidates.Design and support nonclinical and clinical studies, ensuring regulatory compliance.Lead R&D initiatives to enhance ADME/DMPK capabilities across drug modalities.Integrate in vitro, in vivo, and in silico ADME data to refine structure-activity relationships.Represent ADME in regulatory discussions and guide scientists on modern ADME principles. Qualifications:Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutics, Biochemistry, or related field with 6+ years of experience.Strong expertise in drug metabolism, disposition, and pharmacokinetics (discovery and development).Experience with molecular modalities (e.g., biologics, peptides, oligonucleotides).Proficiency in modeling software (e.g., SimCYP, GastroPlus).Excellent communication, collaboration, and project management skills. Additional Information: This opportunity offers a chance to drive innovation and impact patient care while collaborating with a passionate R&D team.