BioNTech SE
Senior Director, Safety Sciences Lead(m/w/x)
Full-timeOn-siteSenior
Mainz, München
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RERevolution Medicines
Senior Director, Qualified Person for Pharmacovigilance(m/w/x)
München
Full-timeOn-siteManagement
Nejo AI Summary
Global pharmacovigilance oversight and EMA/NCA liaison for novel oncology therapies. Advanced degree in Life Sciences or Medicine required. 4-day work week.
Requirements
- 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
Tasks
- 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
Work Experience
- 12 years
Education
- Master's degree
Languages
- English – Fluent
- German – is a plus
- French – is a plus
- Spanish – is a plus
- Italian – is a plus
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Revolution Medicines and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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RERevolution Medicines
Senior Director, Qualified Person for Pharmacovigilance(m/w/x)
München
Full-timeOn-siteManagement
Nejo AI Summary
Global pharmacovigilance oversight and EMA/NCA liaison for novel oncology therapies. Advanced degree in Life Sciences or Medicine required. 4-day work week.
Requirements
- 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
Tasks
- 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
Work Experience
- 12 years
Education
- Master's degree
Languages
- English – Fluent
- German – is a plus
- French – is a plus
- Spanish – is a plus
- Italian – is a plus
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Revolution Medicines and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Revolution Medicines
Industry
Pharmaceuticals
Description
The company is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers.
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