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Teva Mgr Pharmacovigilance India, Karnataka, Bengaluru 762479344
29.08.2024
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The opportunity
- Provide oversight and direction for Pharmacovigilance (PV) Operations case handling activities conducted in the EMIA/APAC Regional PV Operations Hub based in India to support and be compliant to all Health Authority requirements/regulations/laws/guidance in all relevant countries, and all Teva Global requirements.
- Oversee and ensure applicable EMIA/APAC Regional Operations activities (e.g. case intake, triage, data entry, reconciliations, follow-up, submission oversight, etc.) are completed in a timely manner, with high quality, and in compliance with worldwide regulatory and Global PV requirements.
- Overseeing and understanding the process of collecting, assessing, and reporting adverse events that are received within the EMIA/APAC Regional PV Operations Hub, may also provide onsite managerial support for other countries within the International Market and North American cluster when/if required.
- Oversee and ensure all EMIA/APAC Regional PV Operations Hub Key Performance Indicators are completed in a timely manner, with high quality, and in compliance with worldwide regulatory and Global PV requirements.
- Collaborate, and participates, with any initiatives with internal and external colleagues to drive end-to-end process efficiency, harmonization, operational excellence, and compliance at local, regional, and global levels.
- Act as a back-up for direct reports during absences from the office due to vacations, illness, offsite meetings, or attendance at educational events such as seminars/symposia. Act as back-up for the Regional PV Operational Manager for the NA/LATAM Hub.
How you’ll spend your day
- Provide direction and supervision to all team members of the EMIA/APAC Regional Hub and act as back-up when required for the Regional PV Operational Manager for the NA/LATAM Hubs.
- Ensure work is properly organized and undertaken in a manner that meets all requirements of the Health Authorities in EMIA/APAC region, and other applicable regulations issued by other government Health Authorities throughout the world, with respect to pharmacovigilance activities that will be manage and completed by the International Markets & North America Regional Hubs
- Provide ongoing advice and guidance to department personnel.
- Conduct performance appraisals to direct reports, provide input to performance appraisals for indirect reports, and ensure all other full-time regular group personnel are included in a performance management exercise, as per company guidelines and procedures.
- Supervise the selection of all personnel within EMIA/APAC Regional PV Operations Hub.
- Support and contribute to preparation of annual Work Plan budget for International Markets & North America Regional Hubs for any related costs for the EMIA/APAC Region, in collaboration with Regional Pharmacovigilance. Director, and plan and administer work for completion within budget framework.
- Ensure EMIA/APAC Regional employees are adequately trained and equipped with required tools to perform their job.
- Support direct and indirect reports with career development and learning goals.
- Report Writing, Documentation and Record Control for Regulatory Compliance
- Ensure accurate reports and records are created, reviewed, evaluated, analyzed, maintained and where applicable, submitted to applicable Health Authorities for all Adverse Drug Event/Reaction cases received, as per company Standard Operating Procedures and in compliance with the relevant Health Authority requirements/regulations/laws/guidance.
- Support and provides LSOs in EMIA/APAC region accurate written records of all PV case related activities, including but not limited to case intake, triage, data entry, reconciliations, follow-up, submission oversight
- Ensure proper and complete creation, storage and backup of all documentation is organized and maintained in an efficient manner, which will allow for quick retrieval in case of inquiries from health authorities, and to ensure quick recovery from a disaster such as a fire, pest, water damage, etc.
Your experience and qualifications
Bachelors/Master or equivalent in healthcare and life science
10+ years of experience of least 2 years of people management and core pharma industry experience
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