Global Safety Manager (m/f/x) | BAWÜ/ hybrid Unser Kunde ist ein familiengeführtes Pharmaunternehmen, das sich auf innovative Arzneimittel im Feld der Gastroenterologie fokussiert hat. Mit den bestmöglichen Therapien versucht das Unternehmen, die Sicherheit in Alltagssituationen von Betroffenen mit chronischen Darmerkrankungen zu ermöglichen. Welche Aufgaben haben Sie als "Global Safety Manager (m/w/d)"? Überwachung des Nutzen-Risiko-ProfilsSignal-ManagementRisikomanagement inkl. Erstellung von Risikomanagementplänen, Überwachung von RisikominimierungsmaßnahmenErstellung von periodischen SicherheitsberichtenÜberwachung von interventionellen und nicht-interventionellen Studien sowie anderen Datenerhebungen, einschließlich der Erstellung und Überprüfung von studienspezifischen DokumentenUnterstützungdesVorgesetzten:Unterstützung bei der Erstellung von PharmakovigilanzverträgenErstellung und Pflege der Pharmakovigilanz-Stammdokumentation (Pharmacovigilance System Master File, PSMF)Sicherstellung der erforderlichen Qualität der PharmakovigilanzdatenUnterstützung bei GVP-Inspektionen und -AuditsErstellung und Pflege von Standardarbeitsanweisungen (SOPs) für die PharmakovigilanzSelbstständige Durchführung von Pharmakovigilanz-Schulungen für MitarbeiterManagement der Fallbearbeitung und Literaturrecherche inkl. Unterstützung relevanter Dienstleister, Koordination von Reconciliation-Aktivitäten, Erstellung und Pflege von Pharmakovigilanz-ErfassungskonventionenMedizinisch-wissenschaftliche Bewertung von Arzneimittelrisiken und deren Dokumentation unter Berücksichtigung der gesetzlichen Meldepflichten gegenüber den zuständigen Behörden Welche Anforderungen sollten Sie als " Global Safety Manager (m/w/d)" mitbringen? Studium der Pharmazie, Humanmedizin oder in den NaturwissenschaftenLangjährige Berufserfahrungen im Bereich PharmakovigilanzErfahrungen mit GVP - Inspektionen und - AuditsKenntnisse von erstellen der SOPsSorgfältige und genaue ArbeitsweiseTeamfähigkeit und FlexibilitätFließend in Englisch und DeutschHohe ZuverlässigkeitFormularbeginn Was bietet Ihnen das Unternehmen?Vertragsart: unbefristeter VollzeitvertragUrlaub: 30 Tage / Jahr + ZusatzurlaubHomeoffice: alle 4-6 Wochen - mind. 2-3 Tage vor OrtArbeitszeiten: 40 Stunden / WocheZugang: Parkplätze vor Ort und sehr gute Anbindung an öffentliche VerkehrsmittelStarttermin: So bald wie möglich Meine Kontakdaten: Email: inderhees@sciproglobal.deTel: 0049 (0) 89/26 20 09 25 (direct dial)Xing: https://www.xing.com/profile/Marlene_Inderhees/cvLinkedIn: https://www.linkedin.com/in/marlene-inderhees-376a7a16b/ Sind Sie an dieser Stelle interessiert? Dann sollten Sie sich jetzt bewerben! Wenn Sie weitere oder alternative Stellenangebote wünschen, freue ich mich auch über Ihre Bewerbung!Ich freue mich auf Ihre Bewerbung!

Regulatory Affairs Specialist - Medical Devices (m/f/x) | hybrid They commitment to precision and innovation, combined with the scientific expertise of experienced industry professionals, has allowed them to build a strong reputation and establish they products with an international clientele. As part of they team, you'll have the opportunity to contribute to groundbreaking advancements in reproductive healthcare, working in a dynamic environment where quality and excellence are at the forefront. What are your responsibilities as a " Regulatory Affairs Specialist (m/f/x)"?Manage regulatory submissions for medical devices, ensuring compliance with MDR (Medical Device Regulation) and other relevant standards.Prepare, review, and submit technical documentation, ensuring products meet regulatory requirements.Serve as the primary contact with regulatory authorities, handling queries and negotiations.Monitor changes in regulations and ensure timely implementation of new requirements across all relevant departments.Collaborate with cross-functional teams, including R&D, Quality Assurance, and Product Management, to ensure product compliance.Provide regulatory guidance during product development and lifecycle management. What requirements should you bring as a "Regulatory Affairs Specialist (m/f/x)"?A minimum of 3 years of professional experience in Regulatory Affairs within the medical technology or medical devices industry.In-depth knowledge of EU Regulation 2017/745 or 746, as well as other regulatory frameworks, is essentialUniversity degree in a relevant field such as Life Sciences, Engineering, or a related discipline.Experience preparing technical documentation and managing submissions to regulatory authorities.Excellent communication skills and ability to work with cross-functional teams.Fluency in both German and English. What does the company offer you? Contract type: Permanent full-time contract.Vacation: 27 days/yearHome office: Up to 40% remote/mobile.Working hours: 40 hours/week.A dynamic work environment with a flat organizational structureOpportunities to quickly take on responsibility and make a meaningful impactStart date: As soon as possible My contact details:Email: m.inderhees@sciproglobal.deTel: 0049 (0) 89/26 20 09 25 (direct dial)Xing: https://www.xing.com/profile/Marlene_Inderhees/cvLinkedIn: https://www.linkedin.com/in/marlene-inderhees-376a7a16b/ Are you interested in this position? Then you should apply now! If you desire additional or alternative job opportunities, I also welcome your application. I look forward to receiving your application!

Vice President Global Head of Safety REMOTE Competitive Compensation Package Based on Experience Base + Annual Bonus + Stock Options   SciPro Global is partnered with an exciting Clinical Stage Immuno-Oncology Biotech that is gearing up for an NDA in the US, while they have 10 approved products Globally. In preparation for this, they're looking to bring in a Head of Safety to lead Safety Strategy, as well as the overall Safety department. With a strong owned pipeline, and a growing partnered pipeline too, this biotech has plenty of stability and potential.   Responsibilities include (but not limited to): Leading Safety Strategy for entire pipeline of products. Driving the safety strategy during NDA/BLA submission. Building a strong Safety team. Safety operations oversight. Hands on Safety Science work as needed such as aggregate reports, signal detection, benefit risk assessment. Responding to health authority queries regarding safety & risk sections of regulatory documents. Cross functionally act as Safety SME for assigned products & liaise with other Clinical counterparts across the organization. Communicate safety updates with external & internal stakeholders. Provide safety input for clinical study design activities. Identify ways of improvement for team & safety group.   Requirements include (but not limited to): Medical Doctor or Foreign Equivalent Oncology Experience required. Management experience. Experience leading a Safety department. Solution Oriented mindset & motivated!   Are you looking to join a brand name company to grow your career?   Apply now to begin the process!

Senior Global Safety Medical Director  REMOTE Competitive Compensation Package Based on Experience $250,000 - $350,000 + Annual Bonus + Pension   SciPro Global is exclusively partnered with a Stable & quickly growing company that is doing incredible work with a pipeline across Therapeutic Areas from Oncology to Cardiovascular to Immunology to CNS to Respiratory. As they expand their pipeline, there are over 30 programs in Phase 1 & 2 right now leading to multiple positions opening up in their Safety group. This group is solution oriented and full of team players, while being led by a direct, passionate, and impressive leader in the US. This position will report directly into a Therapeutic Area Safety Head and provides unlimited career growth & stability with the technology that they are working on.   Responsibilities include (but not limited to): Safety analysis of both clinical trials & post marketed products. Leading clinical safety aggregate reports such PADERs. Leading risk mitigation and risk minimization measures for global studies, specifically working with RMPs. Responding to health authority queries regarding safety & risk sections of regulatory documents. Perform signal management & lead signal strategy measures. Safety surveillance of all assigned products. Cross functionally act as Safety SME for assigned products & liaise with other Clinical counterparts across the organization. Communicate safety updates with external & internal stakeholders. Provide safety input for clinical study design activities. Identify ways of improvement for team & safety group.   Requirements include (but not limited to): Medical Director or Foreign Equivalent. Minimum 4 years of Pharmacovigilance & Safety experience at a Biotech or Pharma. Solution Oriented mindset & motivated!   Are you looking to join a brand name company to grow your career?   Apply now to begin the process!

Regulatory Affairs Consultant Remote (AUS) - Contract This company is a well-funded biotech firm specializing in the development and delivery of advanced therapies for cancer patients. Their leading-edge research and development focus on providing novel, life-saving therapies for patients with various forms of cancer, striving to improve outcomes and quality of life. Qualifications/Respoonsibilities: Experience filing and aiding in DGA discussions Experience with filing BLA/MAA Scope of the role includes DGA interactions, module 1 (reviewing/updating administrative work) Guide the team through strategic discussions with DGA Provide gap assessment for submissions Experience with biologics, oncology experience (cell therapy preferred)