Job Overview :
The Drug Safety team has an opening for a Project Manager Drug Safety in Costa Rica.
In this position you will manage Client or Project specific Drug Safety 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.
Provide leadership and management of global or regional projects / programs ensuring that communications and processes are harmonized for assigned projects.
Depending on size and scope of project, this job duty may be performed in collaboration with a Principal Drug Safety Project Manager and / or Manager of Drug Safety Solutions and Adjudication (DDSS&A).
Monitor and manage the workflow for assigned projects to ensure all deadlines are met and compliant safety reporting in accordance with International reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team.
Monitor and manage project deliverables regarding contract assumptions; identifying out of scope work or potential to run over budget and escalate to upper management as needed;
and provide necessary data to support Change Notification Forms and / or Change Orders.
Track and monitor changes to the project scope, project schedule, and project costs using appropriate verification techniques.
Maintenance of adverse event reporting requirements in all countries. Responsible for making decisions regarding adverse event reporting within the guidelines of each assigned project.
Responsible for preparation and review of Safety Management Plans (SMPs), Reconciliation Plans and other specific plans, as applicable.
Contribute to the generation and review of Time and Cost Estimates for (DDSS&A) business.
Prepare and deliver safety presentations at investigator meetings, client meetings, and internal meetings as appropriate.
Responsible for preparation and execution of risk management activities and project mitigation plans as needed, in collaboration with other team members.
Consistently contributes to solving technical and / or operational problems by proposing and executing innovative solutions which influence program / project direction.
Provide project specific to training Clinical Operations / Project Management, Client and Investigators as required. Provide support and training in study specific aspects of case-
handling, adverse event reporting and other tasks for team members of assigned projects.
Prepare and participate in internal and external audits, and in regulatory inspections.
Manage the review of cumulative safety data for submission to Drug Safety Monitoring Board (DSMB), regulatory authorities or clients.
Manage the set-up of, and the provision of data to Safety Committees / DSMBs.
Ensure effective cross-functional global teamwork and maintain good team relationship across functional units.
Responsible for cascading relevant information from internal and external meetings to (DDSS&A) management and appropriate colleagues.
Any other duties as assigned by management.
Education / Qualifications :
Minimum Required :
Level of education required (or experience level which may be substituted for level of education).
Professional designations / certifications / licenses required
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 (2-3 yrs safety experience)
PharmD + 2-3 yrs relevant experience (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.
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 preferred
Experience : Minimum Required :
Minimum Required :
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 PV&DSS Management’s team
Good verbal, written and presentation skills.
Anticipate / identify problems and takes appropriate action to correct.
Knowledge of Medical Device Reporting desirable
Knowledge of aggregate reporting
Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.
Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.