Duration: 06 Months Contract
Accountabilities:
- Lead the investigation of late Individual Case Safety Reports (ICSR) submitted to Health Authorities and/or Business Partner, and implementation of corrective and preventive measures, as required
- Generate data, interpret, and perform impact analysis regarding metrics for case processing and regulatory expedited reporting to regulatory authorities and Local Operating Companies (LOCs), including periodic trend analysis.
- Develop and share compliance metrics reports regarding global compliance activities to key stakeholders
- Implement and/or perform Quality Check (QC) activities, as required
- Provide oversight of vendor management activities, as required, which support the Pharmacovigilance compliance department
- Support global efforts to ensure PV regulatory inspection or internal audit readiness for dedicated PV or GCP inspections/audit
- Act as subject matter expert in audits and inspections, where required, and address audit/inspection findings, as needed
- Monitor and manage CAPAs for PSPV to enable on time CAPA completion. Proactively work cross functionally to ensure on-time CAPA completion.
- Partner with LOCs and Drug safety Officers (DSOs) in local inspection/audit activities as needed
- Escalate issues/problems to management, as needed
- Contribute to development of processes and process improvements, as assigned
- Perform other tasks assigned by line manager to assist in departmental activities
- Contribute to business continuity strategies for the activities under their accountability.
Education & Competencies:
- BS, RPH, RN HCP, or Life Science required; experience in the pharmaceutical industry with at least 5 years of relevant experience in pharmacovigilance compliance
- In depth knowledge and comprehension of pharmacovigilance regulations and compliance.
- Knowledge of compliance international Regulations and ICH environment foundations
- Experience with inspections and audit procedures
- Ability to identify proactively and anticipate risk of non-compliance in a complex environment
- Excellent level of computer literacy with Microsoft applications
- Proficiency in safety-related databases (e.g. Argus) and in generating and analyzing compliance metrics
- Project Management experience is a plus
- Excellent organization skills and ability to prioritize
- Demonstrate integrity
- Good analytical/judgment capabilities to understand/analyse/synthesize and communicate
- Able to manage both time and priority constraints and to manage multiple priorities simultaneously
- Take initiative and autonomous action
- Able to lead teleconferences and meetings
- Proven ability to work with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / caching skills
- Bachelor of Science degree in medical or science related field; post-graduate degree or equivalent a plus.
- Excellent interpersonal, communication, and organizational skills.
- Excellent level of computer literacy with Microsoft applications
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Recruiter Details:
Name: Swati
Email: ...@ustechsolutionsinc.com
Internal Id: 25-45031