Regulatory Affairs and Patient Safety Manager require at AstraZeneca
AstraZeneca contributes meaningfully to the UK beyond the provision of our medicines and the benefits they provide to the health of the nation. We commissioned a report in 2009 to measure our significant investment to the UK economy, which includes investment in jobs and wealth creation. Oxera, an independent economic consultancy provided the analysis for this report.
Post : Asia Area Frontier Markets – Regulatory Affairs and Patient Safety Manager
You will be responsible for patient safety and regulatory affairs matters covering data from clinical studies and the marketed use of AstraZeneca products, defined in the Global SOPs as the Asia Area Frontier Markets (AAFM) Regulatory Affairs and Patient Safety Manager. You will report to Director Frontier Markets & Head of Regulatory affairs and patient safety (AA FM) . You will be responsible for managing Sri Lanka , Bangladesh , Myanmar , Brunei , Laos , Cambodia , Maldives.
Key Duties and Accountabilities
• Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate rapid launch
• Interact with relevant regulatory authorities on a regular basis to facilitate the process of obtaining necessary approvals / permissions
• Monitor and understand the impact of external changes in the regulatory environment that will impact on the assigned products
• Communicate the impact of changes to key stakeholders.
• Monitor the global pipelines of competing pharmaceutical companies
• Analyse gathered information for its impact on AstraZeneca proposed pipelines
• Provide scenario with options and a risk – benefit analysis for AstraZeneca going forward
• Monitor status of product licenses and communicate changes to licenses status promptly
• Project manage changes in product licenses and coordinate with other changes, planned and in progress
• Provide Leadership and direction within project teams
• Enhance positive attitudes and mindset. Demonstrate confidence and conviction.
• Challenge status quo for continuous improvement.
• Recording and processing of SAEs from clinical studies, and of adverse events from spontaneous and solicited sources, including pregnancy, overdose, lack of effect, medication errors, product quality complaint or health authority reports according to Global and Local standard operating procedures
Ensures local language medical and scientific literature is periodically reviewed to identify possible case reports, and forwards all the above in a timely manner to the appropriate Data Entry Site (DES) (Patient Safety Standards SOP)
• Ensures that local tracking is maintained in JASPER and captures the date that case reports were received at AstraZeneca, date forwarded to DES, attempts made to obtain follow-up information (applicable to post-marketed reports only), date follow-up data is received, and date submitted to regulatory authorities, where applicable. Where a case has been posted in JASPER but does not qualify for local regulatory submission ensures that the reason is documented. (Patient Safety Standards SOP)
• Providing safety reporting training (and for product quality complaints as required) to other company employees
• Ensures AstraZeneca Pharma India Ltd. personnel are trained on an ongoing basis, on safety reporting requirements and timely reporting to Patient Safety and that any change to Patient Safety procedures is communicated to relevant personnel through appropriate training/coaching.
• Periodic review of Prescribing Information
• Ensures any safety issues/signals in designated therapeutic areas identified by regulatory authorities, media or other local sources or safety related changes to local regulatory requirements are communicated to Global Patient Safety
• Maintains current knowledge of products manufactured and marketed by AZPIL
• Ensure compliance with Local legislation, Global regulatory policies, AZ code of conduct, Corporate Governance and Audit requirement
• Ensure that company confidentiality is maintained (i.e. intellectual property, product information and strategic information)
• Disclose potential breach of codes or conducts
• Medical graduation/ M.Pharm / M.Sc/ PhD
• 6-8 years’ experience in handling Regulatory Affairs and Patient safety (Pharmacovigilance)
• Conversant and relevant experience with Indian regulations related to New product registration, Mfg site registration, Import of new drugs and Clinical trial regulations
• Function specific as well as overall Pharmaceutical industry knowledge
• Ability to build stakeholder relationships
• Strong negotiation and advisory skills
• Analytical mindset and knowledge management
• Passion for Regulatory Affairs and collaborative working style
• Ability to drive performance and act decisively
• Exposure/ Experience in Local Manufacturing activities and PV regulations.
• Knowledge of the latest technical and regulatory developments
• People and organization development ability
Qualification : M.Pharm / M.Sc/ PhD
Location : Bangalore
Experience : 6-8 years
Job ID : R-104644
End Date : 30th April, 2021
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