Work as Associate Lead Surveillance Scientist at AstraZeneca
AstraZeneca’s vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with the aim of bringing six new cancer medicines to patients between 2013 and 2020. A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.
Post : Associate Lead Surveillance Scientist
Lead scientific, technical or Patient Safety input for a product, group of products, systems or processes. He/she has the ability to provide authoring and PV input to safety documents and regulatory reports. PV Scientist also has the ability to lead meetings and present safety data and analyses
• Perform all Surveillance activities including periodic report production, leading monthly signal-detection activities and SIRC activities for established products.
• Authors/provides strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
• Able to produce high-quality and timely responses to safety queries
• Identifies and uses appropriate sources of information and database searches to retrieve relevant data for the evaluation of signals for all products in the area of responsibility.
• Support a performance-driven culture
• Raises appropriate concerns/issues to senior staff in a timely manner.
• Safety Strategy and Management Team (SSaMT) leader for slightly complex products
• Should be able to perform end to end Pharmacovigilance activity independently on 2 or more established products and should mentor others within their role.
• Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes, and procedures
• Compliance with relevant procedural documents Provide strategic & scientific input into regulatory authority submissions, queries, and discussions
• Support response to queries/impositions by regulators, with a high level of attention to implications in other countries
• Ensure good communication and guidance to AZ products
• Liaise effectively and maintain excellent relationship with external contacts
• Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background, with proven competency in patient safety/clinical development
• Comprehensive understanding of applicable Patient Safety regulatory obligations in the EU
• Awareness of Patient Safety policies, processes, and procedures
• Awareness of medico-legal aspects of patient safety
• Up to 7 to 9 years of Patient Safety experience (with clear evidence of delivery
• Total of 9 to 12 years of experience
• Ability to work effectively as a member of a cross-functional or global team
• Ability to work with autonomy
• Ability to acquire and assimilate knowledge in different disciplines, disease, and therapeutic areas
• Good communication skills with the ability to work across cultures
• High ethical standards, including a commitment to AstraZeneca values and behaviors
• Ability to appreciate diversity and work as equals with global and cross-functional teams
Qualification : Qualified to degree level
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Patient Safety
End Date : 30th August, 2019
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