IQVIA

Marketed Product Safety Manager

Company
IQVIA
Location
Dublin
Salary
Negotiable
Posted
17 Oct 2018
Closes
13 Jan 2019
Ref
R1036886

PURPOSE

Coordinate and manage the preparation, review, negotiation and processing of pharmacovigilance agreements. Preparation of pharmacovigilance system master files.

 

RESPONSIBILITIES

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

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