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? Act as the Qualified Delegate of the Local Qualified Person for Pharmacovigilance/ Local PV Responsible Person in Novartis Country Organization for assigned therapeutic areas/ products, including all pre and post approval pharmacovigilance activities as defined by local regulation and applicable legislation

Key Responsibilities

?To be the accountable for specific operational vigilance process(es) at the Country Organization as assigned including local RMP, local signal detection, PSUR, and clinical trial related

?To mentor less experienced staff, maintaining a professional network of key contacts and role model Novartis values and behaviors

?Act as the Qualified Delegate of the Local Qualified Person for Pharmacovigilance/ Local PV Responsible Person in Novartis Country Organization for assigned therapeutic areas/ products, as defined by local regulation and applicable legislation, including:

?To oversight the identification, assessment and control of drug safety risks and ensure the effective implementation of risk control measures

?To be responsible for the management of drug safety information communication and ensure timely and effective communication

?To ensure smooth communication channels within the Marketing Authorization Holders (MAHs) and with the drug regulatory authorities and the drug adverse reaction monitoring authorities

?To be responsible for the review or sign-off of important pharmacovigilance documents

?Act as Qualified Delegate of the Country Patient Safety Head, functional (in terms of responsibility for PV system) for assigned therapeutic areas/ products

?Maintains the oversight, development, coordination, or verification in order to ensure that reporting/ submission/ distribution of safety reports/ updates/ information (e.g. SAE, SR, IN, SUSAR, PSUR, DSUR, GSC, SLC, changes in risk benefit, safety deliverables in CTA/ (s)NDA/ License Renewal/ Reimbursement dossier) is done according to the timeliness described into the respective procedures or as committed with line functions

?Work in close collaboration other local and global medical safety functions to ensure accurate evaluation of safety data

?Conduct local safety signal detection and escalate to global medical safety for potential safety signals identified from all local post-marketing sources per local regulatory requirements

?Lead local RMP and RMP China addendum creation and approval, based on local regulatory or LHA requirement, if applicable

?Interact and exchange relevant safety information with LHA, other functional groups, third-party contractors, and PS associates, as applicable

?Represent PS in China Project Teams (CPT) clinical and submission sub-teams to contribute development strategy and programs from medical safety perspective, and a joint role with global safety leads/ SMTs for safety relevant issues or requests

?Represent PS in CTT and take safety lead responsibilities for Post Approval Commitment (PAC) studies, with the support by global safety lead if needed

?Support the activities with involvement of external experts (e.g. members of trial/ program specific data safety monitoring boards, ad-hoc support for LHA meetings, etc.). Prepares or review safety data for LHA review boards if needed

?Responsible for responses to inquiries from LHA on safety issues related, involve in the communication on safety topics related to responsible products with the LHA

?Monitor national pharmacovigilance regulations and provide update to global PS organization

?Set up, update, and implement local procedures to ensure compliance with PS global procedures and national requirements

?Provide scientific expertise during review of all Phase IV Clinical Trial and NIS protocols safety sections including Research Collaborations and if a Contract Research Organization (CRO) is conducting the trial or study, review safety relevant sections of the contract

?Ensure support for and close-out of audits, corrective action plan, investigation, and Health Authority inspections

?Other agreed tasks assigned by manager

Essential Requirements:

?Health Care Sciences Professional (Medical background, e.g. Medical Doctor is preferred) degree or equivalent training and experience

?At least 5 years experience in pharmacovigilance

or at least 2 years safety/PV physician, clinical physician, or medical affairs experience

Desirable Requirements:

?Project management skills

?Excellent communications and negotiation (networking) skills

?Safety Science, Medical Science

?AI technic

?Fluent in both written and spoken English

?Fluent in both written and spoken local language

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Accessibility and Accommodation:

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.

Pharmacovigilance

Safety Science

Reporting

Waterfall Model

Employee Training

Databases