PROGRAM MANAGER (PV Systems)

Job Description

About our client :

Our client brings together Pharmacovigilance expertise, Third party system knowledge and Deep technology to develop well-defined solutions, which address challenges across Medical Affairs, Regulatory and Safety functions.

Our client solutions free up responsible personnel within Pharma companies to execute their stated responsibilities while staying true to the laws of the land, and ultimately achieving a balance between compliance and managing business risks.

Their solutions are agile, flexible, and scalable, developed using advanced technologies that enables them to serve large and small organizations, both in developed and emerging markets.

JOB DESCRIPTION - PROGRAM MANAGER USA

The Pharmacovigilance Program Manager is responsible for directional leadership of a dedicated Pharmacovigilance (PV) client that is contracted for an extensive suite of PV services while collaborating with Client Services on standard service offerings.

• The PV Program Manager acts with limited oversight and ability to research, implement and manage PV services as contracted or requested;
• is responsible for maintaining a working knowledge of US, Canadian and European PV requirements for investigational and marketed products;

and ensures compliance with all applicable regulations and internal SOPs.

Requirements

Key Role and Responsibilities :

• A minimum of 15-20 years of experience.
• Bachelors OR Masters Degree
• Hands on experience in managing complex projects for large scale global Life Sciences / Pharma Tier 1 & 2 customers.
• Experience in executing large capital projects / programs using various execution strategies.
• Hands on experience in Program Management, Solution Delivery, Stakeholder Management and Risk Management.
• Ensure all projects are delivered on time, within budget and keep track and flag scope changes for revenues.
• Coordinate end-to-end with cross-functional workstreams to ensure those project deliverables are met.
• Develop and manage comprehensive project plans to be shared with clients as well as other stake holders and monitor & track progress.
• Measure project performance using appropriate tools and techniques.
• Build and maintain strong relationships with internal and external stakeholders.
• Perform risk management to minimize project risks.
• Develop systems and processes to automate program management process to improve sustenance, efficiency, and effectiveness.
• Proactively identify and manage project issues and risks.
• Ensure effective communications planning, stakeholder identification and engagement, regular status reporting to key stakeholders (internal and external).
• Understanding of project governance and / or Agile standards and procedures.

Behavioral Skills :

• Demonstrated strong leadership skills and ability to multi-task, self-direct and independently handle cross-functional projects with multiple global stakeholders.
• Ability and willingness to be flexible, adapting to the demands of the customers.
• Exceptional interpersonal skills to interact with a variety of stakeholders and foster cross-functional / cultural teamwork.
• Ability to work in a fast-paced environment, maintaining flexibility and performing at a high level when faced with time constraints.
• Negotiation and conflict management skills.
• Strong critical thinking skills to evaluate alternatives and present solutions consistent with business objectives.

Requirements

Pharmacovigilance, Drug Safety, System Implementation, Project Management, ArisG or Argus