Graduate / PhD / Experienced Scientist - Cambridge, Cambridgeshire, United Kingdom - Energy Jobline ZR

Description

Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them.

Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.

The Global Safety Scientist has a key role within Global Pharmacovigilance & Patient Safety (GPV) and is responsible for providing scientific expertise to safety surveillance and risk management activities including signal detection and evaluation for assigned product(s), where Sobi is the marketing authorisation holder or has product(s) in clinical development.

The role actively contributes to setting the strategic direction within GPV and to the development of safety standards and processes.

As part of our PV team you will be working collaboratively with the Global Product Safety Science Lead (GPSSL) for assigned product(s) as well as with other PV functions, to ensure that safety surveillance activities are delivered to ethical and safety quality standards to ensure the safety of patients and to be in compliance with GVP, GCP and worldwide regulatory requirements.

The Global Product Safety Scientist is directly responsible for providing scientific expertise to safety surveillance and risk management activities for one or more Sobi development and/ or marketed products.

You will be part of a collaborative team made up of safety leads and safety scientists. For the assigned product(s) coordinate multidisciplinary product level Benefit Risk Team meetings for signal detection, analysis and validation, risk management and minimization strategies, risk communication, and safety labelling activities
Contribute to clinical safety science interactions with partner companies for the product (if applicable) to ensure effective clinical safety science interactions including ensuring sharing of safety information per the SDEA and the collaborative functioning of the joint safety management team (JSMT)

Create, extract and/or prepare all types of listings from data sources required from the Sobi Safety Database, or other applicable sources, for the purpose of signal detection, safety surveillance/analysis and regulatory submission activities.

Lead the collection of material for periodic reports e.g. PSURs and DSURs and contribute to the risk evaluation and the benefit-risk assessment for the assigned product(s).
Be main author and coordinator for the production and maintenance of core and EU RMPs and work with stakeholders to support the preparation and maintenance of local RMPs
Provide high quality and timely contributions to responses to safety-related enquiries for Sobi products i.e. from regulatory authorities and other sources requiring input from GPV.

Be the safety representative in clinical study teams, including providing safety input to design, conduct data analysis and interpretation.

Provide safety expertise to CTD submission, regulatory interactions and defence, and geo-expansion beyond initial License Applications (NDA/BLA) and MAAs
In alignment with the GPSSL drive monitoring, aggregation, review, analyses, interpretation, and evaluation of incoming safety information and highlight potential safety signals
Work collaboratively, effectively and flexibly with the GPSSL to complete safety deliverables and activities to ensure continuity of safety support
Product Safety Information
Contribute to development and maintenance of safety related systems, processes, and procedural documents
Education/Learning Experience/Work Experience
A PhD in a topic relevant to the position is
At least 3 years ́ experience post graduation in the pharmaceutical industry, preferably in Patient Safety and/or Clinical/Drug Development, or at a regulatory agency
experience in process development, process implementation, training development and process oversight
High quality written and spoken English
Problem solver, developer of analysis and deliver plans.

With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we're ready to take on the world's diseases, ailments and adversity.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them.

All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to , , or belief, , social or , (including ), , physical, mental or sensory , HIV Status, , , protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.

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