other
Posted 8 hours agoSenior Manager
at Fortrea
Pune, IndiaRemote
Responsibilities
- 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 settings (i.e., unsolicited reports) for specified projects.
- Manage and process expedited adverse events and expedited safety reports to the required standard and ensure submission of them to the client and the regulatory agencies (if required) within the agreed/stated timelines.
- Manage direct reports to ensure staff training records are up to date.
- Oversee the individuals who manages receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial.
- Ensure cases receive appropriate medical review.
- Prepare follow-up correspondence consulting with the medical staff accordingly to Ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines.
- Oversee the management and processing of Expedited Safety Reports (ESRs).
- Review the coding of adverse events Review of reporting of ESRs and endpoints to clients, regulatory authorities, ethics committees, investigators and Fortrea project personnel, if required, within study specified timelines.
- Oversee individuals who manage triage, distribution checklist and quality review of all ESR for assigned projects.
- 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 awareness of Fortrea’s safety database conventions and system functionality.
- Maintain awareness of other client safety database conventions and functionality.
- Ensure that PV PSS teams work closely with the clinical operations and project management groups to ensure all drug safety activities are performed according to the regulatory and contractual requirements.
- Support the appropriate Clinical Data Management (CDM) team(s) in the reconciliation of SAEs across safety and trials databases.
- Prepare the team and participate in audits and or client inspections, either by the client or a regulatory agency.
- Effectively draft/modify and deliver safety presentations.
- Ensure compliant safety reporting in accordance with international reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team.
- Train and mentor new employees overall in pharmacovigilance and regulatory reporting.
- Oversee the maintenance of files regarding adverse event reporting
- Manage the recruitment of new staff to PSS.
- Build and maintain good PSS relationships across functional units.
- Demonstrate role specific Competencies on consistent basis.
- Demonstrate company Values on consistent basis.
- Ensure client and global regulatory compliance.
- These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties.
Requirements
- Maintain a comprehensive understanding of Fortrea PSS’ SOPs, Work Instructions (WI), guidance documents and directives associated with safety management, reporting, and pharmacovigilance Possess knowledge of all other CDCS procedural documents that impact PSS.
- Qualifications (Minimum Required): For PharmD, a one-year residency of fellowship can be considered relevant experience. Fortrea may consider relevant and equivalent
- experience in lieu of educational requirements. English speaking, writing and reading required and local language.
- Ability to interact and influence with line and middle management, staff, and external contacts on a functional and tactical level.
- Ability to multitask and prioritize.
- High degree of accuracy with attention to detail.
- Knowledge of medical and drug terminology.
- Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation.
- Knowledge of worldwide regulatory
- Knowledge of ICH guidelines.
- Qualifications Include: Non-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. relevant experience.
- MS/MA + 5-6 yrs. relevant experience*
- (4-5 yrs. safety experience*). PhD / PharmD + 3-4 yrs. relevant experience*
- 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, Medical Sciences, Life Sciences, or related area.
- 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, working in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance.
- Knowledge of Medical Device Reporting desirable.
- Knowledge of aggregate reporting desirable.
- Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
Experience
- (2-3 yrs. safety experience*) + 1-2 years of team leadership
Additional details
- Job Overview: Line manage PSS staff including performance reviews, human resource issues, and assist Senior PSS Management in assigning resources to projects.
- The post holder is responsible for supporting team members in 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.
- Individual will be expected to comply with the legal
- requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary of
- Responsible for the line-management of individuals within team as well as a project team.
- 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.
- Responsible for office management (schedules, desk assignments, business continuity planning, disaster recovery, etc.).
- Participate in department/process improvement initiatives (identification and implementation).