Project Manager, Drug Safety

Project Manager, Drug Safety

Northern, New Jersey

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. Our Project Manager, Drug Safety will play a key role within ICON’s Pharmacovigilance & Safety Services Group by ensuring that projects within Safety run efficiently, accurately and in accordance with ICON standards, regulatory requirements, and contractual obligations to sponsors and ensure  the daily project operations of assigned safety projects.

Overview of the Role

• Ensure all project safety activities are completed in accordance with ICON SOPs, Study Specific Procedures, regulatory requirements, and Sponsors processes/SOPS.
• Keep management appraised of any potential/actual study or staffing issues and develop solutions for same
• Develop and implement department training
• Assist in training of other departments, as requested
• Maintain quality review metrics and attend project quality meetings, as required
• Maintenance of project budgets and oversight by identifying out of scope activities, change order management, etc.
• Assist upper management with resourcing and business development activities
• Attend bid defence meetings, as requested
• Manage all sizes of drug safety projects, including Sponsor liaison, and management of timelines and budgets, as appropriate
• Ensure audit readiness and/or PVSS representation at audits
• Develop safety plans, study specific procedures, and workflows for clients, as requested
• Actively identify options for process improvement
• Supervise maintenance of project drug safety files as regionally applicable
• Coordinate any committee activities as applicable under supervision
• Perform other activities as identified and requested by management

Supervision

• Manage Safety projects in accordance with established timelines, budget, quality standards and/or contractual requirements
• Develop supporting staff skills, encourage growth and provide regular performance feedback
• Provide project and/or line management of assigned Drug Safety and Administrative staff
• Serve as a mentor and role model for Drug Safety staff

Role Requirements

• A minimum of 4 years of relevant clinical research / pharmaceutical industry experience, preferably with at least 2 years experience in pharmacovigilance / drug safety
• Medical/science background (nursing preferred) and/or bachelors degree or local equivalent
• This position will be required to be on site at the client’s site in Northern New Jersey
• You will have working knowledge of MS Word, Excel and PowerPoint and possess the ability to multitask, remain composed and even-keeled in stressful situations, and perform effectively in spite of shifting priorities, workload and external pressures.
• Ability to interact effectively and professionally with various levels of staff for both internal and external departments, vendors, or Sponsors
• Demonstration of professional demeanour, judgment and discernment in interactions with clients, colleagues, and other staff
• Thorough knowledge of global safety processes and regulations
• Good knowledge of medical terminology, coding systems, aggregate reports, regulatory submission understanding
• Advanced computer skills
• Safety systems knowledge (ARIS-g, ARGUS, etc.)
• Excellent organizational skills
• Excellent communication skills
• Excellent presentation skills
• Ability to mentor staff
• Ability to work independently and lead teams
• Ability to self-start and show initiative
• Detail oriented
• Fluent in written and verbal English

Benefits of Working in ICON

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.   

What’s Next?

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment