Safety Data Manager for Clinical Development (m/w/d) (PR-34161504)

For one of our Munich based lifesciences clients we are looking for someone to take on the role as

Safety Data Manager for Clinical Development (m/w/d)

Tasks:

• Responsible for Safety Data Management across all Clinical sponsored trials and IITs
• Assuring standards and processes for managing safety data are in place according to applicable legislation worldwide
• Provide guidance regarding Safety Data processing to the Case processing vendor and Argus Safety Database host as well as to clinical trial CROs
• Act as the primary contact to vendors regarding case handling and assure outputs of safety data meet the required quality standards
• Assure timely delivery of all required database outputs for clinical development activities ( e.g. Line Listings for aggregate reports, reconciliation)
• Provide GPS vendors with relevant information to maintain compliance including processes in processes and changes in the reference safety information for IMPs and comparator products
• Ensure appropriate training in case processing for clinical trials teams, and study investigators and sites as required
• Support audits and inspections

Requirements:

• Relevant university degree
• Experience in pharmacovigilance
• Excellent organisational skills
• Fluent in English (spoken and written), German is a plus

Parameters:

• Start: asap
• Location: Munich, partly remote
• Volume: full time

Dieser Geschäftszweig der SThree GmbH betreut die ausgeschriebene Stelle im Auftrag ihres Kunden.