Stufenplanbeauftragter / Pharmakovigilanz Experte (m/w/d)Unser Kunde sucht eine Verstärkung, die das Team bei der Sicherstellung höchster Standards in der Arzneimittelsicherheit unterstützt. In dieser Rolle übernimmst du eine zentrale Position und trägst dazu bei, dass alle relevanten PV-Prozesse effizient und professionell umgesetzt werden.Deine Aufgaben:Du bist verantwortlich für die eigenständige Betreuung und Optimierung von Pharmakovigilanz-Systemen und stellst deren kontinuierliche Funktionsfähigkeit sicher.Du übernimmst die Funktion des Stufenplanbeauftragten (m/w/d) und verantwortest die korrekte Implementierung der entsprechenden Prozesse.Du übernimmst selbstständig verschiedene Pharmakovigilanz-Aufgaben, die in internen Projekten anfallen.Du sorgst für die Qualitätssicherung und Einhaltung aller relevanten gesetzlichen Vorgaben im Bereich der Pharmakovigilanz.Du arbeitest aktiv an der Weiterentwicklung von PV-Prozessen und -Standards und bringst deine Expertise ein, um bestehende Systeme und Abläufe zu optimieren. Dein Profil:Du hast ein abgeschlossenes Studium in Medizin, Biologie, Pharmazie oder eine vergleichbare Qualifikation im Bereich Life Sciences.Du hast mehrjährige Erfahrung in der Pharmakovigilanz, insbesondere im europäischen Umfeld, und arbeitest strukturiert sowie analytisch.Du bist mit den relevanten EU-Vorgaben zur Pharmakovigilanz vertraut, insbesondere mit dem Arzneimittelgesetz (AMG) und der Arzneimittel- und Wirkstoff-Herstellungsvoraussetzungen (AMWHV).Du verfügst über sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift.Du bringst die Bereitschaft mit, neue Herausforderungen im Bereich Pharmakovigilanz aktiv zu übernehmen und bestehende Prozesse weiterzuentwickeln.Hohe ethische und fachliche Standards sowie eine klare und verantwortungsbewusste Arbeitsweise sind für dich selbstverständlich.Du bist in der Lage, pragmatische Lösungen zu finden und weißt, wann du Probleme eskalieren solltest.Du arbeitest gerne im Team und förderst eine enge Zusammenarbeit mit verschiedenen internen Abteilungen.Was das Unternehmen bieten:Ein anspruchsvolles und abwechslungsreiches Arbeitsumfeld mit viel Verantwortung.Ein motiviertes Team, das sich auf deine Unterstützung freut.Flexible Arbeitszeiten und die Möglichkeit, auch remote zu arbeiten.Weiterbildungs- und Entwicklungsmöglichkeiten, um deine Expertise auszubauen und in der Pharmakovigilanz noch weiter zu wachsen. Wenn du Teil eines engagierten Teams werden möchtest und die Pharmakovigilanz auf höchstem Niveau mitgestalten möchtest, freue ich mich auf deine Bewerbung!Kontaktdaten:E-Mail: M.Inderhees@sciproglobal.deTel: 089 26 20 09 25

Our client is a small, private clinical-stage biotech developing I&I therapies with best-in-class potential through a range of developmental modalities.The company has forged strategic partnerships with a multitiude of global biotechs, the most recent granting them another ~$200M in additional funding. With the launch of mutilple global Phase II trials, they're looking to add a physician to the team to lead the programs and directly support the CMO. Responsibilites: Drives clinical strategy, overseeing development planning and cross-functional execution while ensuring alignment with corporate goals and optimizing time, resources, and risk.Partners with internal teams and external experts to craft innovative clinical plans. Acts as the clinical lead on core program teams, offering strategic guidance and managing timelines.Directs clinical input for the Product Development Plan, ensuring high-quality contributions. Communicates development strategies and key recommendations to senior leadership and stakeholders.Chairs the Internal Safety Committee, supervising safety monitoring across clinical studies. Oversees medical monitoring and participates in advisory panels and investigator meetings.Contributes to clinical protocols, study reports, and publications, supporting a data-driven publication strategy. Collaborates with academic investigators to share findings in scientific forums.Maintains up-to-date knowledge of regulations, guidelines, and therapeutic advancements, promoting best practices. Represents the company in the medical and scientific community to foster collaboration and industry leadership.Analyzes and interprets efficacy and safety data to generate key insights, aligning messaging with product strategy and clinical applications.Qualifications: MDProven track record of experience and leadership in clinical trials/drug developmentPractical experience including, development of clinical investigational protocols, implementation of protocols, interpretation of data, and interactions with regulatory bodiesExperience with Rheumatology, Immunology, or Autoimmune diseases preferredAbility to manage multiple and diverse internal/external collaborations at different stages of developmentExcellent listening and collaboration skill

Our client is a public, mid-size (~350x heads) biotech using their proprietary gene therapy platform to develop potentially transformative treatments for serious diseases.The company has forged strategic partnerships with major biopharma companies including a development partnership for therapies with blockbuster potential with a Top Ten Global Big Pharma, and licensing agreements with companies leveraging our client's technology for treatments targeting rare genetic conditions.With an upcoming BLA submission, they're looking to add a physician to the team to lead their internal CNS program, as well as take on another CNS development program in the future.The opportunity: As Senior Medical Director, you will lead the development of a transformational gene therapy. You will play a key role in shepherding the candidate drug from pre-clinical stages through launch and lifecycle management. Responsibilites: Responsible for shaping clinical strategy, including development planning and cross-functional execution. Ensures alignment with corporate objectives while balancing time, resources, and risk.Collaborates with internal teams and external experts to design innovative clinical plans. Serves as the clinical lead on core program teams, providing strategic input and overseeing timelines.Leads clinical contributions to the Product Development Plan and ensures high-quality clinical sections. Presents development strategies and recommendations to senior leadership and key stakeholders.Chairs the Internal Safety Committee, overseeing safety monitoring across clinical studies. Manages medical monitoring activities and engages in advisory panels and investigator meetings.Reviews and contributes to clinical protocols, study reports, and publications, supporting a data-driven publication strategy. Engages with academic investigators to present and publish findings in scientific forums.Maintains expertise in regulations, guidelines, and therapeutic areas, ensuring best practices. Represents the company in the medical and scientific community to foster collaboration and thought leadership.Develops strong data analysis skills to interpret efficacy and safety outcomes, shaping key messages in alignment with product strategy and clinical practice.Qualifications: MDProven track record of experience and leadership in clinical trials/drug developmentPractical experience including, development of clinical investigational protocols, implementation of protocols, interpretation of data, and interactions with regulatory bodiesExperience with gene or cell therapies and/or rare orphan diseases preferredAbility to manage multiple and diverse internal/external collaborations at different stages of developmentExcellent listening and collaboration skill

Medical Safety Director Hybrid - Cambridge, MA Competitive Compensation Package Based on Experience$270,000 - $300,000 + Annual Bonus + Stocks SciPro Global is exclusively partnered with a Stable & steadily growing biotech that is doing incredible work with a pipeline across the Immunology and Oncology space. As their pipeline progresses, there are 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 the Senior Director Pharmacovigilance & Safety 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 as 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 Safety experience working at a biotech or pharma.Strong signal detection experience required.Experience as safety lead for investigator brochures.Phase 1 Safety review experience.Solution Oriented mindset & motivated! Are you looking to join an exciting company to grow your career? Apply now to begin the process!

Vice President of Safety REMOTE Competitive Compensation Package Based on Experience One of SciPro Global's standing partners is looking to make their first Safety hire as their pipeline progresses. Our partner is an exciting Clinical stage Immuno-Oncology biotech located in the Massachusetts area. With impressive Clinical progress across different indications and growth over the last year or so, it's now time to make the key hire of a Head of Safety. This individual will be responsible for leading Strategy for safety, pharmacovigilance, and risk, build and manage the team, and collaborate cross functionally. As safety has been outsourced to this point, you will have the opportunity to bring it in house and develop the department accordingly. Reporting directly into the the SVP of Clinical Development, this role will be integral in the organization. Responsibilities include (but not limited to):Provide Safety expertise for all programs in pipeline both in the IO and ADC space.Managing existing PV team member & building the rest of the team.Strategically drive Safety forward while ensuring regulatory compliance.Lead, author and review clinical safety aggregate reports.Leading risk mitigation and risk minimization measures.Responding to health authority queries regarding safety & risk sections of regulatory documents.Perform signal management & lead signal strategy measures.Collaborate cross functionally with clinical development, regulatory, and quality assurance teams.Communicate safety updates with external & internal stakeholders. Requirements include (but not limited to):Medical Doctor or Foreign Equivalent.Minimum 15 years of Pharmacovigilance & Safety experience at a Biotech or Pharma.Experience leading a product through submission.Oncology experience preferred. Are you looking to join an cutting edge company to help the future of Oncology? Apply now to begin the process!