Pharma Job Openings @ ROCHE- Drug Safety Executive Post
Pharma Job Openings @ ROCHE- Drug Safety Executive Post. Drug Safety, Executive, Drug safety executive, Drug safety officer, B Pharma jobs, M Pharma jobs, Pharma jobs, Pharma jobs 2019. Roche invites Pharma candidates for the post of drug safety executive. Check out all the details on the same below:
Job Title: Executive Drug Safety
Work Location: India Mumbai
Eligibility: B Pharma & M Pharma
Job Description:
- 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
- Â 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 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
Behavioral Competencies:
- Team Work and Collaboration
- Inspiring and Influencing
- Communication
- Strategic planning
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