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.
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.