Job title: Associate Director – Patient Safety Scientist
Company: AstraZeneca
Job description: JOB TITLE : ASSOCIATE DIRECTOR
CAREER LEVEL: E
Take the lead to make a bigger impact
Here we need leadership at every level – Physicians who not only have expertise, but also the ability to build a business case, engage multiple stakeholders, and communicate effectively with different audiences. With that kind of remit comes great responsibility and the opportunity to make a big impact.
Be the beating heart of AstraZeneca. A science-driven organisation where
‘following the science’ is backed by investment and bold decision-making.
There’s no better place to see what science can do.
About astrazeneca
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development
About the team
We’re a team of leading specialists, driven to pursue scientific knowledge. And there’s no better place to learn – from the science, from each other and from our failures.
It’s a dual role as we work on both understanding our patients better and contributing to scientific research. We are always learning from people who live with the diseases our medicines treat. So we can make sure that great science born in the lab can make a real difference to their lives.
About the role
Main Responsibilities:
Leads and/or conducts proactive pharmacovigilance and risk management planning for designated products, including preparation of safety aspects of Global Risk Management Plans, in partnership with the GSP and others as appropriate.
Represents PS on cross-functional project teams for marketed products and/or developmental compounds.
Has the ability to present safety information at external meetings.
Has the ability to perform duties as a Safety Strategy and Management Team (SSaMT) leader.
Presents issues to Safety Information Review Committee (SIRC) and has the capacity to take the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders.
Produces accurate and fit for purpose evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
Collaborates with GSP and Clinical representatives and authors the Reference Safety Information (RSI) for assigned marketed products and/or development products; coordinates meetings and tracks timelines to ensure completion.
Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature and other information sources to establish the safety profile of drugs and manage the risk to patients.
Authors/provides strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
Contributes to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreement.
Trains junior members of the team in PS tools and systems.
Authors/provides strategic input to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
Requirements – Education and Experience
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
Awareness of Patient Safety policies, processes and procedures
Awareness of medico-legal aspects of patient safety
9 to 11 years Patient Safety experience
Total of 12 to 14 years of experience
Communication:
The role holder will have:
Well-developed interpersonal skills
Cultural sensitivity
Ability to network with other functions globally
Impact on Business Results:
The role holder will have impact through:
The quality and timeliness of their work through surveillance and case handling activity
The provision of timely information, meeting deadlines for compliance with regulatory reporting requirements for periodic reports, safety due diligence of products, and contributing to correct labeling through safety surveillance activities
Maintenance of efficient and effective process, with focus on productivity
Internal and External Contacts/Customers
Patient Safety personnel at all levels
Regulatory Affairs and other AstraZeneca personnel
WHY JOIN US ?
This is a place of opportunity with the support you need to thrive and grow. You can move around, try different areas and develop new skills.
Most importantly, we get to work on lifechanging medicines for people who face serious conditions. Our innovative discoveries will ultimately have the potential to reach billions of patients’ in need across the globe. That’s why we love it – this is the place to make a greater impact
SO, WHAT’S NEXT?
Are you already envisioning yourself joining our team? Good, because we’d love to hear from you! Click the link to apply and we’ll be in touch as soon as we can.
WHERE CAN I FIND OUT MORE?
Our Social Media, Follow AstraZeneca on LinkedIn
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.
Date Posted 19-Sep-2022
Closing Date
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Expected salary:
Location: Chennai, Tamil Nadu
Job date: Wed, 21 Sep 2022 07:24:23 GMT
Apply for the job now!