Manager -Regulatory Affairs & Patient Safety At AstraZeneca India - Bangalore
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About Us:
At AstraZeneca we are guided in our work by a strong set of values, and we’re resetting expectations of what a biopharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life changing medicines that transform lives. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you’re swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
Job Description
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 Marketing Company Regulatory Affairs and Patient Safety Manager. You will report to Head of Regulatory Affairs and Patient Safety.
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
Essential Requirements
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
Desirable Requirements
Exposure/ Experience in Local Manufacturing activities and PV regulations.
Knowledge of the latest technical and regulatory developments
People and organization development ability
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