Technical Business Analyst for Pharmacovigilance - Job ID: 1493 - ascendis pharma
Palo Alto, CA 94301
About the Job
DescriptionAre you passionate about enabling patient safety with technology? Do you have experience with processes and applications such as the Argus Safety System? If so, now is your chance to join Ascendis Pharma as our new Technical Business Analyst for the Pharmacovigilance IT team.Ascendis Pharma is a fast-growing biopharmaceutical company with locations in Denmark, Germany, the United States, UK, Italy, Spain, and France.
We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives.
Guided by our core values of patients, science, and passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.
Today, we have a growing pipeline of prodrug therapies in development, each designed to be a best-in-class therapy.We are seeking a passionate Technical Business Analyst to join our growing team.
As a key member of the Global IT team, you will play a crucial role in digitalizing our pharmacovigilance team as we embark on an ambitions journey to commercialize our two marketed products across the world.
This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams working together to achieve extraordinary results.You will be part of the Global Pharmacovigilance IT Product Team which consist of 4 people based in Palo Alto, California. The team is known for relentlessly delivering to our drug safety internal customers and utilizing the latest trends in technology to enable business strategy.
The team is fast paced and collaborative. You will report to Saman Sadhar, People Leader in Global IT, and to Ivanna Rosendal, Global Head of Digitalization, from a functional point of view.
Key Responsibilities:Conduct workshops with Pharmacovigilance business executives to design the necessary configuration of the Argus Safety Suite, review business process, Impact/gap analysis, develop technical requirement specificationsArgus Product configuration including reporting Rules, Workflows, E2B, Aggregate Reporting, EDIConfiguration of aggregate reports such as, PADER, DSUR, CSPR etc.Implementing Reports solution using Safety Reporting Application like ORACLE Analytics in conjunction with Oracle ArgusPerform adhoc queries of the database and work with vendor as needed to develop validated queries/reportsCreate reporting solutions with Reporting platforms and services as well as extract, manipulate, and manage data from various sources to ensure accurate and relevant report outputs.Key competencies:You are a strong team player, analytical, and have a can-do attitude.
You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key. To succeed in this role, we also expect you to be a self-starter who can see white spaces and opportunities and jump in to move things forward.
Our team needs to scale to support the ever-growing demands, so we need team members who both can act pragmatically and solution orientated for the short term, and at the same time are able to think long-term to ensure what we do today can grow to support us in the future.
Travel: 10 – 25 days per year.Office: Palo Alto, CaliforniaApply now.Applications will be evaluated when received, so please apply as soon as possible.All applications must be submitted in English and are treated confidentially.RequirementsQualifications and Skills:You hold a relevant academic degree – minimum a bachelor’s degree from a natural science, IT, Digital, Engineering or something completely different5+ years of experience from a related role in a pharmaceutical, biotechnology or related environment. Furthermore, you have:Extensive understanding of PV solutions, industry best practices, multiple business processes or technology designs within a product/technology familyExperience performing varied and complex duties and tasks that need independent judgment, in order to implement PV products and technology to meet business needs.Technical expertise with exposure to migration, customization, upgrades & reporting tools.
Competent in GxP regulations and aware about 21CFR part 11 regulations.Experience in managing change control and managing/generating CAPA documentation if/when needed.Experience in supporting internal and external audits and inspections for PV related systems.Experience from key technical areas, such as: Argus safety solutions, Argus Analytics, Pharmacovigilance Systems, Argus Product Configuration, Data migration, computer System Validation (CSV), GAMP5, E2B R2/R3, and Implementation.
Solid grasp of Oracle Argus Safety system or another PV reporting platform like ArisGlobal LifeSphere MultiVigilance PlatformYou have been working in an agile team, relentlessly improving your working practices. A note to recruiters:We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.Benefits401(k) plan with company match Medical, dental, and vision plans Company-offered Life and Accidental Death& Dismemberment (AD&D) insurance Company-provided short and long-term disability benefits Unique offerings of Pet Insurance and Legal InsuranceEmployee Assistance ProgramEmployee DiscountsProfessional DevelopmentHealth Saving Account (HSA)Flexible Spending AccountsVarious incentive compensation plansAccident, Critical Illness, and Hospital Indemnity Insurance Mental Health resources Paid leave benefits for new parents You can expect an attractive remuneration package, short- and long-term incentives, pension scheme and health insurance.Laptop, iPhone, paid internet, and home office equipment A thorough and structured onboarding programTo succeed in your job and expand in your role, you and your manager will continuously have Impact conversations about how to propel your development.
If a need is identified, we find a way to help you grow.Soft drinks, fresh fruit, and lunch every day in our canteen.Ascendis Pharma headquarters resides in a modern and bright office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals, and the sea.
To ensure a balanced approach to the office, all employees have the opportunity to work from home up to two days per week.Job SummaryID: 5D218CC10DDepartment: Site Management, HR & IT, Global ITType: full time
We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives.
Guided by our core values of patients, science, and passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.
Today, we have a growing pipeline of prodrug therapies in development, each designed to be a best-in-class therapy.We are seeking a passionate Technical Business Analyst to join our growing team.
As a key member of the Global IT team, you will play a crucial role in digitalizing our pharmacovigilance team as we embark on an ambitions journey to commercialize our two marketed products across the world.
This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams working together to achieve extraordinary results.You will be part of the Global Pharmacovigilance IT Product Team which consist of 4 people based in Palo Alto, California. The team is known for relentlessly delivering to our drug safety internal customers and utilizing the latest trends in technology to enable business strategy.
The team is fast paced and collaborative. You will report to Saman Sadhar, People Leader in Global IT, and to Ivanna Rosendal, Global Head of Digitalization, from a functional point of view.
Key Responsibilities:Conduct workshops with Pharmacovigilance business executives to design the necessary configuration of the Argus Safety Suite, review business process, Impact/gap analysis, develop technical requirement specificationsArgus Product configuration including reporting Rules, Workflows, E2B, Aggregate Reporting, EDIConfiguration of aggregate reports such as, PADER, DSUR, CSPR etc.Implementing Reports solution using Safety Reporting Application like ORACLE Analytics in conjunction with Oracle ArgusPerform adhoc queries of the database and work with vendor as needed to develop validated queries/reportsCreate reporting solutions with Reporting platforms and services as well as extract, manipulate, and manage data from various sources to ensure accurate and relevant report outputs.Key competencies:You are a strong team player, analytical, and have a can-do attitude.
You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key. To succeed in this role, we also expect you to be a self-starter who can see white spaces and opportunities and jump in to move things forward.
Our team needs to scale to support the ever-growing demands, so we need team members who both can act pragmatically and solution orientated for the short term, and at the same time are able to think long-term to ensure what we do today can grow to support us in the future.
Travel: 10 – 25 days per year.Office: Palo Alto, CaliforniaApply now.Applications will be evaluated when received, so please apply as soon as possible.All applications must be submitted in English and are treated confidentially.RequirementsQualifications and Skills:You hold a relevant academic degree – minimum a bachelor’s degree from a natural science, IT, Digital, Engineering or something completely different5+ years of experience from a related role in a pharmaceutical, biotechnology or related environment. Furthermore, you have:Extensive understanding of PV solutions, industry best practices, multiple business processes or technology designs within a product/technology familyExperience performing varied and complex duties and tasks that need independent judgment, in order to implement PV products and technology to meet business needs.Technical expertise with exposure to migration, customization, upgrades & reporting tools.
Competent in GxP regulations and aware about 21CFR part 11 regulations.Experience in managing change control and managing/generating CAPA documentation if/when needed.Experience in supporting internal and external audits and inspections for PV related systems.Experience from key technical areas, such as: Argus safety solutions, Argus Analytics, Pharmacovigilance Systems, Argus Product Configuration, Data migration, computer System Validation (CSV), GAMP5, E2B R2/R3, and Implementation.
Solid grasp of Oracle Argus Safety system or another PV reporting platform like ArisGlobal LifeSphere MultiVigilance PlatformYou have been working in an agile team, relentlessly improving your working practices. A note to recruiters:We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.Benefits401(k) plan with company match Medical, dental, and vision plans Company-offered Life and Accidental Death& Dismemberment (AD&D) insurance Company-provided short and long-term disability benefits Unique offerings of Pet Insurance and Legal InsuranceEmployee Assistance ProgramEmployee DiscountsProfessional DevelopmentHealth Saving Account (HSA)Flexible Spending AccountsVarious incentive compensation plansAccident, Critical Illness, and Hospital Indemnity Insurance Mental Health resources Paid leave benefits for new parents You can expect an attractive remuneration package, short- and long-term incentives, pension scheme and health insurance.Laptop, iPhone, paid internet, and home office equipment A thorough and structured onboarding programTo succeed in your job and expand in your role, you and your manager will continuously have Impact conversations about how to propel your development.
If a need is identified, we find a way to help you grow.Soft drinks, fresh fruit, and lunch every day in our canteen.Ascendis Pharma headquarters resides in a modern and bright office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals, and the sea.
To ensure a balanced approach to the office, all employees have the opportunity to work from home up to two days per week.Job SummaryID: 5D218CC10DDepartment: Site Management, HR & IT, Global ITType: full time
Source : ascendis pharma