Global Product Safety Scientist

Job title:

International Product Security Scientist

Firm

Sobi

Job description

Firm DescriptionSobi gives the chance to work at a global pharmaceutical firm targeted on specialty prescription drugs assembly the excessive medical wants of uncommon illness sufferers and offering therapy and companies to them. Our workers come from a wide range of backgrounds inside analysis, healthcare, trade and the educational sphere.Job DescriptionThe International Security Scientist has a key function inside International Pharmacovigilance & Affected person Security (GPV) and is liable for offering scientific experience to security surveillance and threat administration actions together with sign detection and analysis for assigned product(s), the place Sobi is the advertising authorisation holder or has product(s) in scientific growth. The function actively contributes to setting the strategic course inside GPV and to the event of security requirements and processes.
As a part of our PV crew you can be working collaboratively with the International Product Security Science Lead (GPSSL) for assigned product(s) in addition to with different PV features, to make sure that security surveillance actions are delivered to moral and security high quality requirements to make sure the security of sufferers and to be in compliance with GVP, GCP and worldwide regulatory necessities. Additionally, you will be working cross functionally inside the firm and with third events.We’re searching for a motivated and collaborative skilled who will contribute to shaping our crew, develop our programs and processes and drive efficient collaborations throughout Sobi and with our companions.The International Product Security Scientist is immediately liable for offering scientific experience to security surveillance and threat administration actions for a number of Sobi growth and/ or marketed merchandise. You can be a part of a collaborative crew made up of security leads and security scientists. Key obligations embrace however usually are not restricted to:

• For the assigned product(s) coordinate multidisciplinary product stage Profit Danger Staff conferences for sign detection, evaluation and validation, threat administration and minimization methods, threat communication, and security labelling actions
• Contribute to scientific security science interactions with companion corporations for the product (if relevant) to make sure efficient scientific security science interactions together with guaranteeing sharing of security data per the SDEA and the collaborative functioning of the joint security administration crew (JSMT)
• Create, extract and/or put together all varieties of listings from knowledge sources required from the Sobi Security Database, or different relevant sources, for the aim of sign detection, security surveillance/evaluation and regulatory submission actions.
• Lead the gathering of fabric for periodic stories e.g. PSURs and DSURs and contribute to the danger analysis and the benefit-risk evaluation for the assigned product(s).
• Be major writer and coordinator for the manufacturing and upkeep of core and EU RMPs and work with stakeholders to assist the preparation and upkeep of native RMPs
• Present top quality and well timed contributions to responses to safety-related enquiries for Sobi merchandise i.e. from regulatory authorities and different sources requiring enter from GPV.
• Be the security consultant in scientific research groups, together with offering security enter to design, conduct knowledge evaluation and interpretation. Work in shut collaboration with PV Operations to make sure acceptable research case processing.
• Present security experience to CTD submission, regulatory interactions and defence, and geo-expansion past preliminary License Functions (NDA/BLA) and MAAs
• In alignment with the GPSSL drive monitoring, aggregation, overview, analyses, interpretation, and analysis of incoming security data and spotlight potential security indicators
• Work collaboratively, successfully and flexibly with the GPSSL to finish security deliverables and actions to make sure continuity of security assist
• Work throughout PV with the product assigned Partnership and Operations Supervisor to contribute to product particular case administration steerage paperwork and trainings e.g. Product Security Info
• Contribute to growth and upkeep of security associated programs, processes, and procedural paperwork
• Assist audits and inspections for pre-inspection requests in addition to throughout audits and inspections

{Qualifications}Schooling/Studying Expertise/Work Expertise

• College stage qualification in biosciences, healthcare, or pharmacy. A PhD in a subject related to the place is most popular
• At the least 3 years´ expertise publish commencement within the pharmaceutical trade, ideally in Affected person Security and/or Medical/Drug Growth, or at a regulatory company
• Earlier expertise in pharmacovigilance, together with superior/stable data of PV rules and cross-functional working

Abilities/Data

• Analytical expertise
• Skill to work proactively, independently, and collaboratively with colleagues
• Staff-leadership capabilities.
• Relationship builder and collaborator inside PV features Expertise, experience, willpower, and braveness to resolve issues or escalate points as acceptable
• Efficient communicator with friends, internally and with companion features
• Most popular expertise in course of growth, course of implementation, coaching growth and course of oversight
• Prime quality written and spoken English

Private attributes:

• Downside solver, developer of research and ship plans. Confirmed supply focus
• Efficient crew participant

Further InfoAll Sobi workers must reveal behaviors according to Sobi’s core values: Care, Ambition, Urgency, Possession and Partnership. Are you able to be on the Sobi crew? Come be part of a tradition that empowers each particular person to be the individual that makes a distinction for uncommon illness.Why Be part of Us?We’re a world firm with over 1,700 workers in additional than 30 nations and are dedicated to the societies the place we function. With a deeply expert administration crew directing our day-to-day wins, and a Board with a stellar observe document, we’re able to tackle the world’s ailments, illnesses and adversity. Our folks imagine they’ve the ability to make a optimistic influence in others’ lives as a result of that’s precisely what we do right here. When you’re searching for a profession that faucets into your skills in a method that makes the world a greater, more healthy place, we simply might have a job for you.We all know our workers are our most dear asset, and our tradition conveys that. We provide a aggressive advantages bundle, to assist the well being and happiness of our workers.Sobi TraditionAt Sobi, we refuse to simply accept the established order. It is because we now have witnessed first-hand the challenges dealing with these affected by uncommon ailments, and have used this data to form our enterprise to seek out new methods of serving to them.As a specialised biopharmaceutical firm, we’re devoted to uncommon ailments. And we see this focus as a energy. By successfully turning our analysis into ground-breaking therapies, we assist make drugs extra accessible and open up extra prospects for sufferers and extra alternatives for these caring for them. This has been our strategy since day one, however we all know we are able to’t change the world of uncommon ailments on our personal. Carrying out this requires robust partnerships with sufferers, companions and stakeholders throughout all the worth chain. Collectively, we outline how our enterprise can create options that serve the wants of these affected by uncommon ailments whereas facilitating sustainable progress.An Equal Alternative EmployerSobi is an Equal Alternative Employer and prohibits discrimination and harassment of any form. All employment selections at Sobi are based mostly on enterprise wants, job necessities and particular person {qualifications}, with out regard to race, coloration, faith or perception, nationwide, social or ethnic origin, intercourse (together with being pregnant), age, bodily, psychological or sensory incapacity, HIV Standing, sexual orientation, gender identification, protected veterans and/or expression, marital, civil union or home partnership standing, previous or current army service, household medical historical past or genetic data, household or parental standing, or another standing or protected teams by the legal guidelines or rules within the areas the place we function.Sobi is an affirmative motion and equal alternative employer. Disabled/Veterans. If you’re a certified particular person with a incapacity or a disabled veteran, you might request an inexpensive lodging if you’re unable or restricted in your means to make use of or entry this web site to use for a emptiness on account of your incapacity. You possibly can request cheap lodging by sending an e-mail to [email protected].

Anticipated wage

Location

Cambridge

Job date

Thu, 04 Apr 2024 22:21:56 GMT

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