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