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Work as Patient Safety Scientist at AstraZeneca

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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 : Patient Safety Scientist 1

Job Description
Safety Surveillance Scientist works collaboratively with the Global Safety Physician (GSP) and Senior/Principal PV Scientist with the review of safety data and related documents for potential safety issues.  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.

Accountabilities / Responsibilities
• Perform all Surveillance activities including monthly signal-detection activities and SIRC activities for established products with minimal supervision.
• Able to draft the periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines for established products with minimal supervision.
• Able to draft production of high-quality and timely responses to safety queries with minimal supervision.
• Identifies and uses appropriate sources of information and database searches to retrieve relevant data for evaluation of signals in partnership with the GSP, for all products in area of responsibility.
• Support a performance-driven culture
• Raises appropriate concerns/issues to senior staff in a timely manner.
• Has the ability to perform duties as a Safety Strategy and Management Team (SSaMT) leader for smaller or less complex projects
• Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes and procedures
• Compliance with relevant procedural documents
• Ensure good communication and guidance to AZ products
• Liaise effectively and maintain excellent relationship with external contacts
• Support a performance-driven culture

Candidate Profile
• 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 EU
• Awareness of Patient Safety policies, processes and procedures
• Awareness of medico-legal aspects of patient safety
• Up to 4 to 6 years Patient Safety experience (with clear evidence of delivery
• Total of 7 to 9 years of experience
• Ability to work effectively as a member of a cross-functional or global team
• Ability to acquire and assimilate knowledge in different disciplines, disease and therapeutic areas
• Good communication skills with 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
• Good attention to detail
• Good time management
• Delivery focused
• Customer-focused
• Fluent in English
• Computer literate
• Well-developed interpersonal skills
• Cultural sensitivity
• Ability to network with other functions globally

Additional Information
Qualification : B.Pharm, M.Pharm
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
End Date : 27th February 2020


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