Aggregate Report PV Scientist

On behalf of our client, an international pharma company based in Baar, we are seeking a Aggregate Report PV Scientist - Senior Manager.

In this role, you will be a part of the Safety Surveillance and Aggregate (SSA) Reports team and you will be responsible for managing the processes for all aggregate reports (PSURs, DSURs, PADERs and local reports).

You will work closely with the vendors and the vendor oversight team, and with the Quality Management team to ensure high quality standards of the PV documents.
 

General Information:

• Contract type: temporary contract via Randstad
• Start date: ASAP
• Duration: 1 year (with the possibility of extension)
• Location: Baar

Tasks and responsibilities:
 

• 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.

Your profile:
 

• BSc degree in biologic or natural science advanced degree (MSc, PhD, MPH, PharmD, etc.)
• Minimum 8- 10 years Pharmacovigilance experience, including experience in aggregate safety reports writing and safety signal management. Minimum of 2 years managing direct reports.
• 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 
• Management and authoring of aggregate data reports.
• Represents and speaks to processes in cross-Safety and cross-functional forums.
• 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.

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