As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
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 typically, but not exclusively, responsible for providing line management of junior PSS staff.
Manage, coordinate, and oversee the overall PSS operations associated with the processes for 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. 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.
He/she will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health & Safety Manual.
Summary of Responsibilities:
Responsible for the line-management of individuals within 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.
Responsible for office management (schedules, desk assignments, business continuity planning, disaster recovery, etc.).
May lead or assist with the management of PSS concerning project allocation and resourcing.
General oversight for 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, oversight of the following types of tasks:
Entry of safety data onto adverse event 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 cases receive appropriate medical review.
Prepare follow-up correspondence consulting with 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 Fortrea project personnel, if required, within study specified timelines.
File maintenance.
General oversight for the management and processing of Expedited Safety Reports (ESRs). This includes, but is not limited to, oversight of the following types of tasks:
Review and update adverse event databases and tracking systems.
Review of adverse events for completeness, accuracy, and appropriateness for ESR.
Review of patient narratives.
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.
File maintenance.
Maintain awareness of Fortrea’s safety database conventions and system functionality.
Maintain awareness of other client safety database conventions and functionality.
May prepare, but definitely provide oversight to the timely preparation of pharmacovigilance reports for products and safety issues, including Individual Case Safety Reports (ICSR) of Serious Adverse Events (SAEs) and aggregate reporting.
Provide oversight and management of EudraVigilance activities for assigned projects.
Contribute to the generation and review of Time and Cost Estimates for PSS business.
Support the appropriate Clinical Data Management (CDM) team(s) in the reconciliation of SAEs across safety and trials databases.
Prepare and participate in audits, either by the client or a regulatory agency.
Consistently contributes to solving technical and/or operational problems identified by program/project members.
Consistently proposes and executes innovative solutions which influence program/project direction.
Generation of monthly status, staff member performance and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
Effectively draft/modify and deliver safety presentations:
Client capabilities meetings, as appropriate.
“Department Overview” to internal clients.
Attend client meetings and liaise with clients where appropriate.
Ensure compliant safety reporting in accordance with international reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team.
Responsible for cascading relevant information from internal and external meetings to direct reports and appropriate colleagues.
Train new employees overall in pharmacovigilance and regulatory reporting.
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 Patient Safety Solutions.
Assist with the generation and review of SOPs, Work Instructions etc.
Responsible for SOP implementation within assigned team.
Assist in developing Operational metrics measuring PSS’ overall performance. ¨ Assist with
the recruitment of new staff to Patient Safety Solutions.
Build and maintain good PSS relationships across functional units.
Demonstrate role specific Competencies on consistent basis.
Demonstrate company Values on consistent basis.
Financial authority as it relates to personnel and projects.
Any other duties as assigned by management.
*The above job duties are completed by the staff as applicable, depending on the role they are assigned to.
Qualifications (Minimum Required):
Focus on customers.
Innovative and able to change.
Pursue scientific and progress excellence.
Work with others.
Achieve results.
Experience (Minimum Required):
Strong relationship-building and interpersonal skills.
Good ability to assess staff performance and propose effective strategies to enhance existing strengths and fill any noted skill or knowledge gaps.
Good ability to propose solutions to effectively address any performance issues.
Ability to provide mentorship and guidance to project support staff.
Ability to grow and develop project support staff through multiple levels within the department career ladder.
Ability to coach project support staff in development of technical skills, efficiency, and quality.
Ability to work independently in a staff management capacity, in regular consultation with management.
Ability to perform project review and process analysis, identify potential risks and process improvements – and propose appropriate action.
Functions as a positive, engaging, and motivating team player.
Ability to direct, manage and coordinate the day-to-day efforts of multiple levels of staff.
Ability to effectively balance multiple concurrent priorities in a fast-paced, complex setting.
Ability to effectively manage multiple internal and external customers competing concurrently for attention, services, and resources.
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.
Work collaboratively with PSS Management’s team.
Leadership capabilities.
Good communication.
High degree of accuracy with attention to detail.
Ensure client and global regulatory compliance.
Will present and share useful business information across departments and functions.
Anticipate/identify problems and takes appropriate action to correct.
Knowledge of medical and drug terminology.
Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation.
Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.
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.
Financially intuitive.
Knowledge of ICH guidelines.
Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.
Preferred Qualifications Include:
EudraVigilance Certification.
Non-degree 7+ yrs safety experience* including 2 years of team leadership experience***
Physical Demands / Work Environment:
Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location.
Office environment or remote.
No special factors at this time.
Job Location : Bangalore
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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