Job Description :
Ensures that collection, reporting and handling of safety information associated with Roche products is performed according to global Roche and local regulatory requirements.
• Maintains oversight of LSU activities and management of safety information, safety risk management and all other pharmacovigilance (PV) activities, ensuring PV medical compliance (Roche policies and procedures, global and local regulatory requirements) and inspection readiness for country(ies) within their area of responsibility.
• To review and access all the source documents for reporting adverse events from all spontaneous and solicited sources and track into respective PV tools/local trackers
• To ensure effective communication with internal/external stake holders in context to any discrepancy, follow-ups regarding safety information.
• To review, access and submit the individual case safety reports to Regulatory Authority in timely manner and track the submission in safety database, tracking tool and systems
• Collaborate with Regulatory team and supply chain and logistic team to ensure timely submission of aggregate reports to Regulatory authority based on the approval of the product and track the submission records in local tracker, systems and tools
• To collaborate with legal, supply chain and logistics to assess requirement of PV agreement execution.
• To ensure the process for patient centric distribution network in collaboration with DST team
• To Ensure PV oversight for direct markets
• To maintain oversight of the out of hours coverage and testing mechanism of reporting , records management and archiving, SOP and process and adverse event training completion activities for all Roche Users
Functional & Behavioral Competencies
• Knowledge of Pharmacovigilance information
• Knowledge of PV relevant regulations (ICH, EMEA, US FDA and local regulatory Authority)
• Knowledge of Medical Terminology – Verbal and written
• Team Work and Collaboration
• Inspiring and Influencing
• Communication
• Strategic planning
• Knowledge of Pharmacovigilance information
• Knowledge of PV relevant regulations (ICH, EMEA, US FDA and local regulatory Authority)
• Knowledge of Medical Terminology – Verbal and written
• Team Work and Collaboration
• Inspiring and Influencing
• Communication
• Strategic planning
Additional Information
Location : Mumbai, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Drug Safety
End Date : 20th May, 2019
Location : Mumbai, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Drug Safety
End Date : 20th May, 2019
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