Covance Senior Associate Drug Safety (QPPV), Russia/ Ukraine in MOSCOW, Russia
Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:
entry of safety data onto adverse event database(s) and tracking systems
review of adverse events for completeness, accuracy and appropriateness for expedited reporting
write patient narratives
code adverse events accurately using MedDRA
determine expectedness/listedness against appropriate label
identifies clinically significant information missing from initial reports and ensures its collection
ensure case receives appropriate medical review
prepare follow-up correspondence consulting the medical staff accordingly
ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines
reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines
provide independent QC of AE reports for other members of the group
May execute routine quality review of AE reports and aggregate reports for other members of the group ensuring that case processing and data quality meet global regulatory compliance needs including audit support
Maintain a strong understanding of Covance's safety database conventions or client-specific database conventions, as appropriate.
Participate in signal detection, trend and pattern recognition activities, as appropriate.
Prepares timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, European Annual Safety Reports (ASRs), Development Safety Update Report (DSUR) Periodic Reports (PRs) line listings, and aggregate reports.
Begin to participate and demonstrate leadership on projects which enhance team and/or division performance. This includes acting as a lead contact for projects including global projects ensuring communication and process harmonization.
Work with Data Management or client on reconciliation of safety databases, if appropriate.
Monitor workflow for assigned studies/programs to ensure all deadlines are met.
Draft/modify and deliver safety presentations
Serious Adverse Event reporting at Investigator meetings
Client capabilities meetings, as appropriate
"Department Overview" to internal clients
Maintains a comprehensive understanding of Covance PV &DSS' Standard Operating Procedures (SOPs), Work Instruction(WI), guidance documents and directives associated with safety management reporting and pharmacovigilance.
Possess knowledge of other procedural documents, e.g. SOPs, etc. that impact PV &DSS.
Assist in the development of departmental Work Instructions (WI) and Standard Operating Procedures (SOPs), as appropriate.
Ensure compliant safety reporting in accordance with US and international reporting regulations, SOPs and safety processing guidelines set forth by departmental management team and the client.
Participate in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics/data are provided.
Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting and other work, as needed.
Build and maintain good PV &DSS relationships across functional units.
Demonstrate role-specific Competencies on a consistent basis.
Demonstrate company Values on a consistent basis.
Begin to prepare Safety Management Plans (SMPs), Reconciliation Plans and other safety specific plans under supervision.
Responsible for making decisions regarding adverse event reporting within the guidelines of each specific project.
Assist PV &DSS management to identify out of scope work.
Actively participates in project team and client meetings and liaise with clients, where appropriate.
Prepare and/or participate in client or regulatory audits.
Assist in the review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients.
Assist with the set -up of, and the provision of data to Safety Committees/DSMBs.
Assist in the co-ordination of endpoint committees, as required.
Any other duties as assigned by management.
Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry. In lieu of degree we can consider candidate with relevant 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. Expereince of acting as a QPPV for Russia/Ukraine is a must.
Proven experience in processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
Good verbal, written and presentation skills.
Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level.
High degree of accuracy with attention to detail.
Functions as a team player.
Ability to present and share useful business information across departments and functions.
Ability to anticipate and identify problems and take appropriate action to correct.
Knowledge of medical and drug terminology
Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
Knowledge of ICH Guidelines
Knowledge of Medical Device reporting desirable
Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.
Good knowledge and understanding of industry processes and objectives.
Ability to work independently with minimal supervision
Good keyboard skills with knowledge of MS office and Windows.
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.