Drug Safety Manager

Drug Safety Manager

ICON's award-winning study execution capabilities have led to the approval of 18 of the world's top 20 best-selling drugs. ICON seek an expert pharmacovigilance professional with expertise in managing client relationships and projects along with the expertise of mentoring a team.

The Drug Safety Manager will manage a team of Drug Safety Associates within ICON's Pharmacovigilance & Safety Services Group, which offers safety support across all stages of the product lifecycle by providing efficient drug safety processes, compiling concise drug safety profiles, and developing tailored risk-management strategies.

About the Drug Safety Manager role within ICON:

The Drug Safety Manager will serve as the main point of contact for the customer for the life cycle of assigned stand-alone projects. You will manage assigned teams to ensure project and departmental deliverables are being met, within budget limits and with approved quality levels to support achievement of the department's overall financial and quality goals and objectives;

• Line management of Drug Safety Associates
• Ensuring that safety information is adequately and timely reported to the authority.
• Acts as primary contact point for authority in pharmacovigilance matters.
• Contact local regulatory and/or health authorities when necessary for the conduct of the clinical trial including communication of Serious Adverse Event.
• Liaising with other local stakeholders in PV matters, for example: with Local team members concerning updates to local safety information.
• Prepare and perform quality checks of global pharmacovigilance intelligence requirements
• Ensure all assigned project and departmental activities are completed in accordance with ICON standards, regulatory requirements, and contractual obligations to Sponsors.
• Assisting the Director/Senior Director to develop and grow capabilities, efficiency, and quality levels.
• Actively participate in quality and training initiatives.
• Lead identification of out-of-scope activities and process efficiency/improvement needs or implement contract amendments/change orders as required.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions;

• Previous experience in pharmacovigilance or other equivalent clinical or pharmaceutical experience
• Excellent understanding of global regulations are related to pharmacovigilance and safety processes
• Bachelor's degree or local equivalent in pharmaceutical, nursing or science
• Excellent computer skills (Microsoft Word, Excel, Outlook, Access) and advanced safety database proficiency
• Excellent decision-making abilities
• Excellent interpersonal skills
• Ability to lead teams and guide/mentor staff
• Excellent organizational, time management and problem-solving skills
• Strong sense of responsibility and dedication
• Proficient in written and verbal English

Benefits of Working in ICON

In comparison with our competitor's and pharmaceutical companies, we provide more flexible and reasonable working platforms for coaching and educating new comer's to be highly respected professionals in our industry. ICON also provides successful candidates with an excellent employment package and benefits adapted to the current job market. We are more like an extended family with consideration of staff as individuals allowing a work-life balance.

Additionally, we have innovative technology that will allow you to analyze study specific processes, audit reports, and governance to quality system checks and ensure compliance.

What's Next

Following your application, if you have the necessary skills and experience for this job you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment