Product Safety Lead

Jobinhalt

Site Name: Belgium-Wavre
Posted Date: May 10 2021

Job Purpose

• You ensure decisions on safety issues made in line with common principles/thresholds for concern.
• You understand scientific relevance/impact of safety signals and product quality issues across product portfolio.
• You have the ability to handle complex safety issues independently when they arise, particularly those impacting on benefit risk
• You lead and coordinate the cross-functional assessment in the Safety Review Team (SRT)
• You lead and coordinate the scientific evaluation of safety data and risk management for complex product portfolios and/ or product families in clinical development and in the global market.
  
  

Key Responsibilities

You ensure compliance with relevant PV activities and processes for allocated products Including the following:

• Signal detection and evaluation of safety for assigned product families.
• Manage the evolving safety profile of assigned vaccine product families
• Provide appropriate and timely Benefit Risk Assessments for assigned vaccine projects
• Design, tracking and follow up of risk management plans for the products assigned and assure their sound implementation.
• Lead the Safety Review Team for assigned vaccine projects
• Represent the safety profile of assigned product families in internal and external meetings
• Development and revision of assigned central pharmacovigilance processes and related training.
• Accountable for answering and follow-up of enquiries from regulatory authorities and other bodies (e.g., Ethics Committees) regarding safety-related aspects.
• Contact person for authorities for any safety related question
• Implementation of the applicable regulations for the assigned vaccines.
• Participate in IDMC meetings or other safety related interactions
• Review safety data exchange agreements for products assigned.
  
  

Why you?

Basic Qualifications

• University degree in Veterinary Medicine, Biology, Chemistry, Biochemistry, Pharmacy or equivalent.
• Minimum 5+ years of experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance, Drug Safety or a related field.
• In depth understanding of the regulatory environment (e.g. International, US and European Legislation), specifically in safety regulations and working methods.
• Excellent mastery of English, written and spoken with highly effective communication skills.
• Strong leadership and collaborative working skills
• Ability to manage crisis/issues independently, monitor safety issues and work under pressure with a customer and solution oriented approach.
• Able to prioritise activities effectively and to meet multiple deadlines successfully with attention to detail, setting high performance standards for quality
  
  

Preferred Qualifications

• PV expert and expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to Safety.
• An additional degree (e.g. PhD, MBA, MSc, MPH) or specialization is a plus.
  
  

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

Job Purpose

• Ensures decisions on safety issues made in line with common principles/thresholds for concern.
• Understands scientific relevance/impact of safety signals and product quality issues across product portfolio.
• Ability to handle complex safety issues independently when they arise, particularly those impacting on benefit risk
• Lead and coordinate the cross-functional assessment in the Safety Review Team (SRT)
• Lead and coordinate the scientific evaluation of safety data and risk management for complex product portfolios and/ or product families in clinical development and in the global market.
• This may involve working in partnership with other functions in VCSP such as the Patient Safety & Manufacturing Liaison, but also for selected areas independently to deliver the following:  Coordinate and perform the safety analysis of adverse event reports and/or signal detection activities for assigned therapeutic areas and/or product families in clinical development as well as post-licensure  Be the safety contact person for internal and external stakeholders for assigned vaccine projects  Provide input to Clinical Teams with respect to safety aspects of the design and preparation of protocols, informed consent forms, investigators brochures, investigator letters and reports, for the follow up and processing of clinical study data and lead the safety analyses of the assigned projects.  Ensure creation, maintenance and implementation of (D)CSI (Development, Core Safety Information) for the assigned projects.  Ensure provision of the Benefit Risk Assessment and risk identification, assessment and mitigation activities for assigned vaccine projects
  
  

Key Responsibilities

Ensures compliance with relevant PV activities and processes for allocated products Including the following:

• Signal detection and evaluation of safety for assigned product families.
• Manage the evolving safety profile of assigned vaccine product families
• Provide appropriate and timely Benefit Risk Assessments for assigned vaccine projects
• Design, tracking and follow up of risk management plans for the products assigned and assure their sound implementation.
• Lead the Safety Review Team for assigned vaccine projects
• Represent the safety profile of assigned product families in internal and external meetings
• Development and revision of assigned central pharmacovigilance processes and related training.
• Accountable for answering and follow-up of enquiries from regulatory authorities and other bodies (e.g., Ethics Committees) regarding safety-related aspects.
• Contact person for authorities for any safety related question
• Implementation of the applicable regulations for the assigned vaccines.
• Participate in IDMC meetings or other safety related interactions
• Review safety data exchange agreements for products assigned.
  
  

Why you?

Preferred Qualifications

• PV expert and expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to Safety.
• An additional degree (e.g. PhD, MBA, MSc, MPH) or specialization is a plus.

Li-GSK

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

Patient-focused Research and Development (R&D) is the heart of our business. Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist. Part of our R&D programme targets diseases particularly prevalent in the developing world, including the World Health Organisation’s three priority diseases - HIV/AIDS, tuberculosis and malaria. Research into candidate vaccines for other diseases of the developing world, such as dengue are at an earlier stage of development.

When it comes to developing the vaccines of the future, we’re looking for real experts in their respective fields who are interested in working in the stimulating environment of an international healthcare company.

We emphasise the value of teamwork and we look for people ready to share our values of transparency, respect, integrity and patient focus.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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