Summary:
The position has two responsibilities. The extent of the secondary role will be balanced with the demands of the primary role.
Primary Role:
- To recruit, manage and ensure effectiveness of Post-marketing Safety Scientists and Safety Science Resources
- To be responsible for process improvements in Safety Science
Secondary Role:
- Provide safety analytical support to the Lead Product Safety Physician (LPSP)
- Support the creation and maintenance of a single interpretation of global safety data for marketed products
- Assist in identifying and managing evolving safety concerns with marketed products
- Support signal detection and analysis of aggregate safety data
- Maintaining knowledge of safety profiles for treatments in the hematology/oncology therapeutic area
Outputs:
• Resource Plans
• Process Mapping
• SOPs/WPs pertaining to drug safety
• Drafting of regulatory responses to safety enquiries
• Analysis of signal detection outputs and draft reports
• Literature Reviews
• Drafting Safety Topic reviews / other Safety summaries
• Drafting of abstracts/publications and slide decks
• Company Core Data Sheet / Product Labelling updates
• Collaboration on Risk Management Plans

Knowledge:
• Knowledge of international global regulations and guidances pertaining to drug safety
• Knowledge of Industry principles of drug safety, drug development, pharmacology, biostatistics and pharmaco-epidemiology.
• Knowledge of signal recognition and statistical techniques
• Assessment, interpretation & presentation of aggregate safety data
• Knowledge of commercial drug environment
• Knowledge of oncology/hematology patient populations and drug classes
• Experience with safety-related risk management, in particular signal confirmation, health hazard assessments, and/or risk mitigation.
• Working knowledge of safety database systems
• Mastering of safety data capture in clinical trial and post-marketing settings
• Knowledge of MedDRA Medical Coding principles

Competencies:
• Managing Staff
• Critical thinking
• Decision making
• Scientific leadership
• Organization and planning
• Communication skills
• Ability to interpret, analyze and clearly present scientific and technical data (oral and written)
• Ability to work with minimal supervision
• Ability to thrive in a global matrix environment

Qualifications
Prerequisites:
- Minimum of BSN or PharmD or the equivalent combination of relevant education and professional experience.
- Eight (8) years of biotec/pharma experience, of which five (5) should be in post-marketing drug safety