Global Head of Drug Safety
Who We Are
Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery systems.
We are driven by the exciting and unique goal of addressing unmet patient and consumer needs by revitalizing, repurposing, and reimagining existing therapies to better serve people in taking care of their health and wellbeing.
What We Will Deliver
We focus on the development of a proprietary pipeline of wellness and healthcare products, with a specific focus on highly differentiated products that address unmet medical and consumer needs.
By leveraging our unique and enabling R&D capabilities, we are building a pipeline that includes inhalable medicines and consumer wellness products.
About the role:
As Senior Safety Science Lead, you will be reporting to the Head of Regulatory Affairs and Pharmacovigilance and working in close links with the regulatory, clinical and medical functions, the Chief Medical Officer as well as other relevant functions throughout the organization.
As Senior Safety Science Lead, you will play a critical role in ensuring the safety and well-being of patients using our pharmaceutical, healthcare and wellness products worldwide. You’ll oversee activities and processes related to monitoring adverse events, assessing risks, and implementing safety measures. Your expertise will contribute to the overall success of our development and post-marketing activities.
Core responsibilities:
• Develop and execute the global safety strategy (clinical and post-marketing) aligned with regulatory requirements and company goals.
• Establish processes and provide oversight to ensure adequate monitoring of safety signals, trends, and emerging risks related to our products.
• Contribute to the development of core clinical trial related documents including but not limited to Protocol, Investigator Brochure (IB) and Informed Consent Forms (ICF).
• Lead the cross functional Safety Management Team (SMT) and provide strategic guidance on all safety matters and collaborate with cross-functional stakeholders.
• Lead the safety strategy and Benefit/Risk Management Process
• Provide strategic oversight, direction for regulatory safety responses or other safety deliverables including but not exclusive to safety sections of NDAs/MAAs, RMPs, PSURs/DSURs etc.
• Development and maintenance of reference safety information
• Balance the use of inhouse and external resources effectively to meet safety objectives.
• Foster a culture of excellence, continuous learning, and collaboration.
Role Requirements:
• Medical degree (MD) with significant relevant experience
• In-depth understanding of global pharmacovigilance regulations (ICH, FDA, EMA, etc.)
• Broad experience from previous roles involving consumer health, OTC as well as prescription products and advantage.
• Proficiency in benefit-risk assessment methodologies.
• Strong leadership, communication, and decision-making abilities.
• Ability to work effectively with cross-functional teams and external partners.
• Demonstrated ability to communicate strategy, issues, and risks in written and verbal format
• Ability to handle ambiguity, short deadlines and fast changing environment.
• Proven capabilities working in a matrix organization.
Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery systems.
We are driven by the exciting and unique goal of addressing unmet patient and consumer needs by revitalizing, repurposing, and reimagining existing therapies to better serve people in taking care of their health and wellbeing.
What We Will Deliver
We focus on the development of a proprietary pipeline of wellness and healthcare products, with a specific focus on highly differentiated products that address unmet medical and consumer needs.
By leveraging our unique and enabling R&D capabilities, we are building a pipeline that includes inhalable medicines and consumer wellness products.
About the role:
As Senior Safety Science Lead, you will be reporting to the Head of Regulatory Affairs and Pharmacovigilance and working in close links with the regulatory, clinical and medical functions, the Chief Medical Officer as well as other relevant functions throughout the organization.
As Senior Safety Science Lead, you will play a critical role in ensuring the safety and well-being of patients using our pharmaceutical, healthcare and wellness products worldwide. You’ll oversee activities and processes related to monitoring adverse events, assessing risks, and implementing safety measures. Your expertise will contribute to the overall success of our development and post-marketing activities.
Core responsibilities:
• Develop and execute the global safety strategy (clinical and post-marketing) aligned with regulatory requirements and company goals.
• Establish processes and provide oversight to ensure adequate monitoring of safety signals, trends, and emerging risks related to our products.
• Contribute to the development of core clinical trial related documents including but not limited to Protocol, Investigator Brochure (IB) and Informed Consent Forms (ICF).
• Lead the cross functional Safety Management Team (SMT) and provide strategic guidance on all safety matters and collaborate with cross-functional stakeholders.
• Lead the safety strategy and Benefit/Risk Management Process
• Provide strategic oversight, direction for regulatory safety responses or other safety deliverables including but not exclusive to safety sections of NDAs/MAAs, RMPs, PSURs/DSURs etc.
• Development and maintenance of reference safety information
• Balance the use of inhouse and external resources effectively to meet safety objectives.
• Foster a culture of excellence, continuous learning, and collaboration.
Role Requirements:
• Medical degree (MD) with significant relevant experience
• In-depth understanding of global pharmacovigilance regulations (ICH, FDA, EMA, etc.)
• Broad experience from previous roles involving consumer health, OTC as well as prescription products and advantage.
• Proficiency in benefit-risk assessment methodologies.
• Strong leadership, communication, and decision-making abilities.
• Ability to work effectively with cross-functional teams and external partners.
• Demonstrated ability to communicate strategy, issues, and risks in written and verbal format
• Ability to handle ambiguity, short deadlines and fast changing environment.
• Proven capabilities working in a matrix organization.
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Neuchâtel, Switzerland
Quai Jeanrenaud 3 Neuchâtel
Neuchâtel 2000
Switzerland
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About the company
Neuchâtel / Basel
