[Hiring] Associate Director PSS @Fortrea

Role Description

Responsible for managing the Patient Safety Solutions (PSS) regional operations group (Europe, Asia-Pacific or The Americas). Key responsibilities include:

• Ensuring all domestic projects are allocated and set up according to capabilities and workload.
• Training and developing assigned staff.
• Maintaining project timelines and budgets.
• Processing expeditable adverse events and submitting them to clients and regulatory agencies within agreed timelines.
• Overseeing service provision to clients, either as a support function or as a stand-alone business.
• Complying with legal requirements of the Health and Safety at Work Act 1974, COSHH regulations 1989, and EC Directives 1992/3.

Qualifications

• RN + 10 yrs. relevant experience
• BS/BA + 8 yrs. relevant experience
• MS/MA + 6 yrs. relevant experience
• PharmD + 4 yrs. relevant experience
• Relevant experience in the pharmaceutical, biotechnology, or CRO industry, including areas such as Medical Affairs, Clinical Data Entry, Clinical Data Management, Regulatory Affairs, Quality Assurance, or Drug Safety.
• At least 6 years of experience specifically in safety/AE processing and a minimum of 4 years supervisory experience.
• Language Skills: Speaking and writing/reading in English and local language.

Requirements

• At least 4 years line management and/or project management experience.
• Industry experience with 6+ years relevant to drug safety knowledge.
• Good verbal, written, and presentation skills.
• Ability to interact and influence with line and middle management, staff, and external contacts.
• Leadership capabilities and good communication skills.
• High degree of accuracy with attention to detail.
• Knowledge of medical and drug terminology, Good Clinical Practice (GCP), worldwide regulatory requirements, ICH guidelines, and Risk Management and Pharmacovigilance.
• Good keyboard skills, preferably with knowledge of MS Office and Windows.
• Financially intuitive.

Benefits

• Office environment or remote home-based office, as negotiated.
• Available for travel 15-20% of the time, including overnight stays as necessary.