Ref #: 30797

Employment type: Permanent - Full-Time

Location: Belgium

Posted: 20-Jul-2021

Description

Key Responsibilities:

• The PV Scientist is part of the Safety Surveillance and Aggregate (SSA) Reports team of Global Safety and Regulatory Sciences (GSRS) and is responsible for managing the processes for all aggregate reports (PSURs, DSURs, PADERs and local reports) and for associated pharmacovigilance activities for assigned product or group of products, including where required overseeing signal management activities, responses to ad hoc regulatory requests, literature, and clinical trial safety activities.
• The PV Scientist serves as subject matter expert on aggregate reporting safety requirements worldwide for the PV Scientist team, Safety and Biogen cross-functionally.
• Responding to safety questions from internal and external stakeholders, reviewing and supporting with authoring of medical and scientific safety information.
• The PV Scientist works closely with the vendors and the vendor oversight team, and with the Quality Management team to ensure high quality standards of the PV documents.
• Support with initiatives for process improvement, and collaborating with the PV Sciences group, other Safety Staff and cross-functional groups to develop, implement and maintain processes that are compliant with global PV regulations, improve efficiency and lead to consistent work processes across assigned product groups taking into account cross-program practices.
• Project management and authoring of aggregate safety reports such as PSURs, DSURs, PADERs, local reports in collaboration with the PV scientist Lead.
• Serves as a subject matter expert on relevant safety requirements, company policies/procedures related to pharmacovigilance activities, as well as aggregate reports knowledge.
• Support with process improvement; implements and maintains processes.
• Responsible for the Aggregate Reports Master Schedule and worldwide legislation overview (Production, update, stakeholders review).
• In collaboration with PV Scientist lead coordinates and authors responses to safety questions from regulatory authorities.
• Contributes to initiatives for process improvement and consistency regarding aggregate reporting, Clinical trial safety oversight, signal management and responding to ad hoc safety questions.




Required experience and qualifications:

• Bachelor’s Degree in biologic or natural science Advanced degree (MSc, PhD, MPH, PharmD, etc.)
• Minimum 5 years Pharmacovigilance experience, including experience in aggregate safety reports writing and safety signal management.
• Fluent communication skills in English & Dutch
• Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
• Interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues.
• Leads and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests. Oversees and mentors less experienced PV Scientist staff.
• Management and authoring of aggregate data reports.
• Represents and speaks to processes in cross-Safety and cross-functional forums.
• Successfully manages substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests performed by direct reports.
• Applies clinical judgment to interpret case information, helps guide staff on clinical judgment and interpretation of case information.
• Familiarity with Pharmacovigilance and drug development, including knowledge of applicable
• Clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts.
• Strong organizational skills, including the ability to prioritize independently with minimal supervision.
• Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word,
• Business Objects). Knowledge of common safety database systems.


Remuneration & other details

• Possibility to get a foot in the door of one of the biggest and most successful global pharmaceutical companies and develop an interesting career in the pharmaceutical domain
• Home-based possibilities
• Unlimited permanent contract
• Friendly work atmosphere
• Competitive fringe benefits package (company car + fuel card, insurances, recuperation time, pension, meal-vouchers, eco-cheques, …)



Benefits of Working at ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Would you like to know more? Please submit your CV to ken.falorni@docsglobal.com or via our homepage www.docsglobal.com. We are looking forward to your application.