Labcorp are recruiting for a Manager/Senior Manager PSS to join the team.Role responsibilities:Line manage PSS staff including performance reviews, human resource issues, and assist Senior PSS Management in assigning resources to projects.Manage the overall 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.Responsible for the line:management of individuals within a team as well as a project team.Manage direct reports to ensure staff training records are up to date.Responsible for managing performance reviews and issues of direct reports.May manage individuals across multiple teams and will take on responsibility for cross department projects.Education/Qualifications:Minimum Required:Level of education required (or experience level which may be substituted for level of education).Professional designations/certifications/licenses requiredNon:degree + 10 yrs safety experience*Associate degree + 8:9 yrs safety experience*Associate degree RN + 7:8 yrs safety experience*BS/BA + 6:7 yrs safety experience*MS/MA + 5:6 yrs relevant experience** (4:5 yrs safety experience)PharmD + 3:4 yrsrelevant experience** (2:3 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.*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.**Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.EudraVigilance Certification preferredExperience:Required:
