BioNTech SE
Senior Director, Safety Sciences Lead(m/w/x)
Vollzeitnur vor OrtSenior
Mainz, München
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RERevolution Medicines
Senior Director, Qualified Person for Pharmacovigilance(m/w/x)
München
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Global pharmacovigilance oversight and EMA/NCA liaison for novel oncology therapies. Advanced degree in Life Sciences or Medicine required. 4-day work week.
Anforderungen
- Advanced degree in Life Sciences, Pharmacy, Medicine, or related field
- Medical degree strongly preferred
- In-depth knowledge of GVP
- In-depth knowledge of EU PV legislation
- In-depth knowledge of global regulatory frameworks
- Proven experience managing global PV systems
- Proven experience interacting with health authorities
- Excellent understanding of drug development
- Excellent understanding of life-cycle management of medicinal products
- Regulatory expertise
- Strategic thinking
- Strong leadership skills
- Strong communication skills
- Strong organizational skills
- Track record of leading high performing team
- Track record of building high performing team
- Ability to manage complex global PV operations
- Excellent stakeholder management skills
- Excellent decision-making skills
- Excellent influence capabilities
- Excellent collaboration capabilities
- Excellent teamwork capabilities
- Strong organizational skills
- Strong time management skills
- Ability to prioritize tasks
- Ability to manage multiple tasks effectively
- Located within the EU/EEA
Aufgaben
- Ensure compliance with pharmacovigilance obligations
- Maintain oversight of global PV system
- Oversee product safety profiles
- Act as primary contact for EMA and NCAs
- Escalate safety concerns
- Recommend urgent regulatory actions
- Safeguard patient safety worldwide
- Ensure regulatory compliance worldwide
- Drive compliance with global PV regulations
- Foster a culture of safety and vigilance
- Establish and maintain the Pharmacovigilance System Master File (PSMF)
- Establish inspection readiness
- Act as primary contact for authorities 24/7
- Establish and maintain the PV System
- Ensure PV System is appropriate and effective
- Collect, process, and report safety information
- Oversee GVP implementation
- Maintain oversight of PV activities by affiliates and vendors
- Act as legally designated QPPV
- Ensure compliance with EU PV legislation
- Promote, maintain, and improve PV compliance
- Ensure PSMF accurately reflects PV system
- Manage regulatory inspections related to PV
- Act as main interviewee during GVP inspections
- Manage CAPA process
- Maintain awareness of product safety issues
- Maintain awareness of marketing authorization conditions
- Maintain awareness of risk management plans
- Ensure conduct of PV activities
- Ensure quality of PV data submitted to authorities
- Respond to authority requests for information
- Provide input on regulatory actions
- Ensure timely submission of PSURs and PASS
- Review and approve Risk Management Plans
- Ensure risk minimization measures are implemented
- Nominate and oversee a qualified deputy QPPV
- Maintain documented back-up procedures
- Oversee PV system functioning
- Oversee quality system, including SOPs and training
- Delegate specific tasks to qualified individuals
- Act as a member of the GPS Leadership Team
- Lead cross-functional risk/crisis management committees
- Coordinate PV activities across affiliates and partners
- Inform and support PV audit planning
- Provide PV guidance to internal teams and external partners
- Support due diligence for business development
- Represent GPS in interdepartmental meetings
- Represent MAH in European and International PV community
- Lead, mentor, and manage Local Safety Responsible personnel
Berufserfahrung
- 12 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – ist ein Plus
- Französisch – ist ein Plus
- Spanisch – ist ein Plus
- Italienisch – ist ein Plus
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Revolution Medicines erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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- BioNTech SE
Senior Director Quality Transformation and Oversight(m/w/x)
Vollzeitnur vor OrtSeniorMünchen - BioNTech SE
(Senior-) Director Clinical Development(m/w/x)
Vollzeitnur vor OrtSeniorMainz, München - BioNTech SE
Director Global Regulatory Affairs (Oncology)(m/w/x)
Vollzeitnur vor OrtSeniorMainz, München - Apellis
Senior Director, General Manager(m/w/x)
Vollzeitnur vor OrtSeniorMünchen
RERevolution Medicines
Senior Director, Qualified Person for Pharmacovigilance(m/w/x)
München
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Global pharmacovigilance oversight and EMA/NCA liaison for novel oncology therapies. Advanced degree in Life Sciences or Medicine required. 4-day work week.
Anforderungen
- Advanced degree in Life Sciences, Pharmacy, Medicine, or related field
- Medical degree strongly preferred
- In-depth knowledge of GVP
- In-depth knowledge of EU PV legislation
- In-depth knowledge of global regulatory frameworks
- Proven experience managing global PV systems
- Proven experience interacting with health authorities
- Excellent understanding of drug development
- Excellent understanding of life-cycle management of medicinal products
- Regulatory expertise
- Strategic thinking
- Strong leadership skills
- Strong communication skills
- Strong organizational skills
- Track record of leading high performing team
- Track record of building high performing team
- Ability to manage complex global PV operations
- Excellent stakeholder management skills
- Excellent decision-making skills
- Excellent influence capabilities
- Excellent collaboration capabilities
- Excellent teamwork capabilities
- Strong organizational skills
- Strong time management skills
- Ability to prioritize tasks
- Ability to manage multiple tasks effectively
- Located within the EU/EEA
Aufgaben
- Ensure compliance with pharmacovigilance obligations
- Maintain oversight of global PV system
- Oversee product safety profiles
- Act as primary contact for EMA and NCAs
- Escalate safety concerns
- Recommend urgent regulatory actions
- Safeguard patient safety worldwide
- Ensure regulatory compliance worldwide
- Drive compliance with global PV regulations
- Foster a culture of safety and vigilance
- Establish and maintain the Pharmacovigilance System Master File (PSMF)
- Establish inspection readiness
- Act as primary contact for authorities 24/7
- Establish and maintain the PV System
- Ensure PV System is appropriate and effective
- Collect, process, and report safety information
- Oversee GVP implementation
- Maintain oversight of PV activities by affiliates and vendors
- Act as legally designated QPPV
- Ensure compliance with EU PV legislation
- Promote, maintain, and improve PV compliance
- Ensure PSMF accurately reflects PV system
- Manage regulatory inspections related to PV
- Act as main interviewee during GVP inspections
- Manage CAPA process
- Maintain awareness of product safety issues
- Maintain awareness of marketing authorization conditions
- Maintain awareness of risk management plans
- Ensure conduct of PV activities
- Ensure quality of PV data submitted to authorities
- Respond to authority requests for information
- Provide input on regulatory actions
- Ensure timely submission of PSURs and PASS
- Review and approve Risk Management Plans
- Ensure risk minimization measures are implemented
- Nominate and oversee a qualified deputy QPPV
- Maintain documented back-up procedures
- Oversee PV system functioning
- Oversee quality system, including SOPs and training
- Delegate specific tasks to qualified individuals
- Act as a member of the GPS Leadership Team
- Lead cross-functional risk/crisis management committees
- Coordinate PV activities across affiliates and partners
- Inform and support PV audit planning
- Provide PV guidance to internal teams and external partners
- Support due diligence for business development
- Represent GPS in interdepartmental meetings
- Represent MAH in European and International PV community
- Lead, mentor, and manage Local Safety Responsible personnel
Berufserfahrung
- 12 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – ist ein Plus
- Französisch – ist ein Plus
- Spanisch – ist ein Plus
- Italienisch – ist ein Plus
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Revolution Medicines erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Revolution Medicines
Branche
Pharmaceuticals
Beschreibung
The company is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers.
Noch nicht perfekt?
- BioNTech SE
Senior Director, Safety Sciences Lead(m/w/x)
Vollzeitnur vor OrtSeniorMainz, München - BioNTech SE
Senior Director Quality Transformation and Oversight(m/w/x)
Vollzeitnur vor OrtSeniorMünchen - BioNTech SE
(Senior-) Director Clinical Development(m/w/x)
Vollzeitnur vor OrtSeniorMainz, München - BioNTech SE
Director Global Regulatory Affairs (Oncology)(m/w/x)
Vollzeitnur vor OrtSeniorMainz, München - Apellis
Senior Director, General Manager(m/w/x)
Vollzeitnur vor OrtSeniorMünchen