מציאת משרת הייטק בחברות הטובות ביותר מעולם לא הייתה קלה יותר
Teva Sr PV Professional India, Karnataka, Bengaluru 944387550
07.01.2025
How you’ll spend your day
- Participate in activities of literature review. Design and implement comprehensive literature search strategies on specific products. Knowledge of database: Embase, Medline, Pubmed, Ovid, etc.
- Assess the impact of regulatory changes on the current process.
- Contribute to simplification of processes.
- Knowledge and expertise in Teva portfolio.
- End to end case processing experience including intake, triage, case processing, quality check and submissions and investigating and resolving E2B rejections with successful submission.
- Serious, and non-serious case processing experience of business partners, health authorities, social media, non-interventional studies, legal case processing, literature case processing experience, clinical trials, and PSP/MRP/IIS. In depth knowledge of various case processing conventions, scenarios and have processed variety of cases with the mix of Literature, business partner, spontaneous, health authority with achieving daily/monthly/yearly productivity.
- Act as a consultant or SPOC for various case related activities and maintain knowledge repository of the process updates/ regulatory changes changes on real time.
- Effective communications to be maintained with internal (related departments and units) & external (partners, authorities, vendors) stake holders in order to run the process as transparent as possible.
- Ensure that quality data is analyzed for any trending and to prepare team for process stabilization.
- Ensure regulatory compliance by following internal reporting key performance indicators for the unit are met.
- Independent operations and self-promoted initiatives are expected to interpret and make valuable decisions in ever changing and dynamic requirements from regulators.
- Being part of transitions to the team and to other teams and certification of the teams on the same.
- Conduct various interactive activities like workshops, trainings, sessions to educate the team on the existing and on predicted error trends for process improvements.
- Provide the analytical support for the peers and managers in investigations and analysis of various trends as a part of audits, and inspections.
- Mentoring the new hires with case processing knowledge transfer, evaluating their progress close to perfection during their initial phases of learning curves.
- Perform other tasks assigned by the direct manager.
- Supported for major health authorities’ Audit/inspections as presenter to auditors and submitted the auditors’ requests after through quality check.
- Involvement in SOP reviews and provided the changes with thorough review of ICH, GVP guidelines etc. and worked as mentor in CAPA/deviations writing, investigating, monitoring, tracking until final completion.
- Experienced in gap analysis and multiple stakeholders’ interaction for various projects in pharmacovigilance department.
- Involvement in various data correction projects and cleanup projects in safety database.
Your experience and qualifications
- Any life sciences/pharmaceutical/healthcare professional graduate (B. Pharmacy, M. Pharmacy, Pharm D, BDS).
- Minimum of 4-6 years of experience in pharmacovigilance including literature review process in ICSR
- Experience in patient safety/pharmacovigilance: solid knowledge in pharmacovigilance concepts, regulations, and procedures.
- Advanced knowledge of Microsoft Office platforms.
- Flexible to adapt to shifting team priorities.
- Excellent communication skills including written, verbal, and non-verbal.
- Excellent Interpersonal and people skills. Good analytical skills and problem-solving skills.
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