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.

Head of Clinical Pharmacology & DMPK SciPro has partnered with a small molecule, stealth biotech backed by a top-tier Venture Capital firm, offering a highly collaborative and entrepreneurial environment. Focused on targeting cholesterol homeostasis, we are advancing multiple CNS therapeutic programs and scaling towards NDA filings. They are seeking an experienced Head of Clinical Pharmacology & DMPK to lead and own their Clinical Pharmacology function across all phases of development (IND, Phase I-III, and NDA filings). This role reports directly to the Chief Scientific Officer (CSO) and offers the opportunity to make a significant impact on our programs as we prepare for Phase 2 Proof-of-Concept (POC) studies and NDA submissions. Key Responsibilities:Lead and own the Clinical Pharmacology function for NDA submission and oversee all related Nonclinical activities.Develop in vitro and in vivo ADME screening and DMPK study plans for early research programs.Support dosing decisions and interpret data using PK software.Collaborate with and oversee external parties for modeling work and data interpretation.Partner with the CSO and leadership team to drive development and execution of clinical studies.Contribute to the growth and scaling of a rapidly evolving biotech, bringing hands-on expertise and leadership. Qualifications:PhD and 10+ years of experience in the pharmaceutical indsutry.Extensive experience in Clinical Pharmacology & DMPK, with a proven track record of supporting IND through NDA stages.Expertise in in vitro and in vivo ADME screening, DMPK study plans, and dosing strategies.Proficient in PK software and data interpretation.Experience collaborating with external partners for modeling and related activities.A self-starter and "builder" mindset, with the ability to adapt and thrive in a fast-paced biotech environment. What They Offer:The chance to work with a highly successful and visionary C-Suite leadership team.A stable financial backing, with ongoing funding rounds to support clinical advancements.The opportunity to shape the future of CNS therapies in a mission-driven, innovative organization.

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.