Patient Safety Agreement Management - Manager

Patient Safety Agreement Management - Manager

What you will do

Lets do this. Lets change the world. In this vital role you will need to have the ability to effectively prioritise and run a diversified workload, often to strict deadlines. Strong interpersonal skills, a professional approach with excellent written and verbal communication skills are a must.

• Assessment of PV-related clauses in business agreements
• Leads the preparation, negotiation and conclusion of PVAs, amendments and terminations
• Acts as a key contact point for the end-to-end lifecycle management of Pharmacovigilance Agreements (PVAs) with internal and external key partners
• Handles safety agreement monitoring activities
• Runs development of process related documentation to ensure compliance
• Leads regular and ad hoc meetings with Business Partners and provides support to resolve business partner issues with respect to PV activities
• Handles Incidents/CAPAs liaising with external and internal stakeholders as needed
• Develops and runs systems for monitoring and tracking of non-conformance
• Mentors new staff in areas of expertise as needed
• Actively support PV audits and inspections as they pertain to PVAs and work with QA/Compliance function to support the partner audit program
• Share knowledge of all relevant regulatory guidance and standards (e.g. FDA, ICH and EMEA PMDA)
• Provide hands-on contributions to cross-functional project teams and delivering on schedule
• Provide a pro-active approach to initiatives within the pharmacovigilance department and in cross-functional efforts
• Identify and implement opportunities to improve operational efficiencies and identify, avoid, and/or minimize the risks of regulatory and contractual non-compliance and other business loss
• Contributes to standards around which others will operate. Responsible for the day-to-day operations for key activities.
• Negotiate, implement, maintain and oversee fulfilment and regulatory compliance of global PV Agreements (PVAs) with business partners

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The PSAM Manager, is expected to be a self-starter, to demonstrate knowledge and expertise in pharmacovigilance and to effectively collaborate with all relevant departments and personnel, business partners and as needed, with the regulatory authorities worldwide.

Basic Qualifications:

• Doctorate degree OR
• Masters degree and 4 to 6 years of directly related experience OR
• Bachelors degree and 6 to 8 years of directly related experience OR
• Diploma and 10 to 12 years of directly related experience
• Excellent command of the English language (written and spoken)
• Pro-active communicator
• Strong technical competency
• Strong attention to detail
• Recognize and call out issues
• Time Management
• Strong written communications
• Strong Planning - Problem Solving
• Strong Customer Focus
• Building Effective Teams
• Leading and Measuring Work
• Strong Presentation Skills
• Strong Interpersonal Skills
• Process Management
• Conflict Management
• Negotiation Skills
• Motivation Skills
• Organizational Skills
• Global Business Knowledge
• Microsoft Suite - Outlook, Word, Excel, PowerPoint (proficient)
• Knowledge of Regulatory and Safety functional activities - Pharmacovigilance systems
• Principles associated with compliance, regulatory inspections and audits in global environment
• Regulations governing Pharmaceutical Industry