[Hiring] Project Manager Drug Safety @Fortrea

Role Description

Manage ‘Client’ or ‘Project’ specific PSS operations associated with products including the entire adverse events process, which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports) for specified projects. Manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. The post holder is responsible for providing this service to clients either as a support function to the client project groups or as stand-alone business. Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. The role will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual.

Qualifications

• Non-degree + 6-7 yrs. Safety experience*
• Associate degree + 5-6 yrs. Safety experience*
• Associate degree RN + 5-6 yrs. Safety experience*
• BS/BA + 4-5 yrs. Safety experience*
• MS/MA + 3-4 yrs. relevant experience** or 2-3 yrs. Safety experience*
• PharmD + 2-3 yrs. relevant experience** or 1-2 yrs. Safety experience*
• For PharmD, a one-year residency of fellowship can be considered relevant experience.
• Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.

Requirements

• Compliance with client and global regulatory requirements.
• Good knowledge of the relevant worldwide pharmacovigilance regulations and guidelines.
• Good knowledge of Good Clinical Practice (GCP) related to clinical safety documentation.
• Good knowledge of ICH guidelines.
• Good knowledge of medical and drug terminology.
• Work collaboratively with PSS Management’s team.
• Good verbal, written and presentation skills.
• Good communication.
• Leadership capabilities.
• Anticipate/identify problems and take appropriate action to correct.
• Knowledge of aggregate reporting.
• Aware of the regulatory environment regarding Risk Management and Pharmacovigilance.
• Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
• Financially intuitive.

Company Description