Marketed Product Safety Manager
Coordinate and manage the preparation, review, negotiation and processing of pharmacovigilance agreements. Preparation of pharmacovigilance system master files.
Manage the day-to-day safety agreement development process for large complex projects
Act as safety agreement expert and key interface for internal staff ensuring consistency in approach, metrics and format
Manage project requirements, identify issues and interact with customers to resolve issues.
Assist in the negotiation of safety agreement text using approved processes and templates
Participate in complex negotiations of safety agreements as required.
Resolve safety agreement disputes and / or escalate irreconcilable issues to management team
Perform quality control edits on all documents
Provide advice, support and guidance as needed and serve as a mentor to colleagues
Represent safety agreements team at customer meetings and on internal task forces as required
Assist in the training and mentoring of safety agreements team
Prepare and maintain PSMFs
Reviews PSMFs prepared by other specialists
Work closely with team members to ensure collaboration and efficient working practice.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
In-depth knowledge of Lifecycle Safety service lines
Proven staff management skills.
Excellent project management and communication skills.
Strong leadership, motivational and influencing skills.
Ability to work on multiple projects and manage competing priorities effectively
Effective mentoring and developed coaching skills.
Strong judgment, independent thinking, decision-making and problem solving skills.
Ability to establish and maintain effective working relationships with co-workers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree or educational equivalent in health science or other directly related field and clinical research experience in a Contract Research Organization or Pharmaceutical company combining Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management etc) and project management experience or equivalent combination of education, training or experience