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45 Fortrea Development India Private Limited Jobs
Director / Sr. Director, Client Partnerships, Patient Safety Services
Fortrea
·
15-20 years
Bangalore / Bengaluru
1 vacancy
Director / Sr. Director, Client Partnerships, Patient Safety Services
Fortrea Development India Private Limited
posted 22hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Acts as a primary safety leadership point for clients. Manage all client communications, and governance, etc
- Responsible for the project finance management and quality and compliance of the overall deliverables.
- Contribute to planning for future state business, including but not limited to development of new pricing models, development of proposals for new organizational models, identification of key process improvements, development of business cases for new service offerings.
- Demonstrate ownership for/orchestrate/oversee successful implementation of multiple concurrent departmental and corporate initiatives on a domestic, regional, and global scale.
- Identify need for department initiatives, develop plan for implementation, quantify measures of success, oversee successful execution, measure results.
- Represent Safety in cross-functional, corporate initiatives.
- Maintain complete understanding of Fortrea s safety database conventions and system functionality.
- Provide oversight to the timely preparation of pharmacovigilance reports for products and safety issues, including Individual Case Safety Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, Periodic Reports (PRs) and Periodic Safety Update Reports (PSURs).
- Match available adequately trained staff resources to business needs.
- Ensure competency and skills are appropriate to projects and provide identified training needs.
- Ensure departmental working practices are in accordance with training and identify any areas requiring clarification or additional training.
- At project win stage, ensure that allocation of resources is predicted and managed for all projects o Apprise the Executive Director, PSS of resource requirements in advance of new projects or when additional coverage may be required in times of excess volume of work.
- Provide support to other members of PSS Management Team for periods of absence, vacation and busy periods.
- Review metrics to evaluate current safety workload to forecast impact on future staffing needs.
- Participate in interviews, selection and training of new PSS staff members.
- Generate and maintain a productive working environment for all teams in the region.
- Provide effective direct management of PSS operations staff.
Experience (Minimum Required):
- At least 8 years project management/ client management experience.
- Industry experience of which 15+ years is relevant to pharmacovigilance/drug safety knowledge
- 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:
Advanced degree preferred.
Advanced degree preferred.
Employment Type: Full Time, Permanent
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based on 711 employees
Flexible timing
Monday to Friday
No travel
Day Shift
Fortrea Development India Private Limited Benefits
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Fortrea Development India Private Limited Bangalore / Bengaluru Office Location
Bengaluru Office
MSR Vaishnavi 29 Union Street, Near Cubbon Park Metro Station, Shivaji Nagar, Bengaluru, Karnataka 560001
Bengaluru
560001
560001
Director / Sr. Director, Client Partnerships, Patient Safety Services
15-20 Yrs
Bangalore / Bengaluru
Associate Grants Payments (AP or Billing backgrouind)
1-4 Yrs
Bangalore / Bengaluru
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