Pharmacovigilance Scientist Level I
Welwyn Garden City (Hertfordshire)
Job description
Job facts
Who we are
We're innovation, curiosity and diversity – multiplied by 80,000 professionals in 150 countries. As a global leader in research-focused healthcare, we're constantly learning and growing – and seeking people who share these goals.
The Position
Roche is a global leader in pharmaceutical research and in order to uphold our high standards and commitment to delivery in respect to drug safety, we are looking to develop our Pharmacovigilance team.
You will be accountable for providing molecule-driven support for ICSRs, including the processing of high quality, accurate and medically cohesive safety reports in line with regulatory and company timelines and requirements as well as other activities supporting the ICSR process.
Your other accountabilities will include:
• Supporting other ICSR processes including: Serious Adverse Event (SAE) reconciliation, Pharmacovigilance/Safety Data Exchange Agreement review and implementation and performing Blind Breaks.
• Representing PDSO on an ad hoc basis at Study Management Team meetings.
• Creating and maintaining Data Handling Guides for assigned molecules.
• Assisting with audit and inspection readiness activities.
• Collaborating with Safety Science and other colleagues in order to develop and maintain in-depth knowledge on specific molecules and corresponding disease biology, and relevant study/program expertise.
• Representing PDSO at internal and external forums, communicating PDSO accountabilities, deliverables and achievements as appropriate.
• Undertaking additional tasks and projects, as assigned, in support of PDSO or PDS, or other business goals.
· Who we are
Our UK Pharmaceutical head office is situated in Welwyn garden City, Hertfordshire, with beautiful country side surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. With over 1400 people occupying our site in Welwyn, you can expect opportunities in Early Development (pRED), Product Development (PD), Commercial (Rx) and of course our corporate function.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
Desired profile
Who you are
You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
Who you are
You are a health care professional or hold a life science degree in a related subject. You have excellent attention to detail and also have or be willing to develop a good knowledge of global Pharmacovigilance regulatory obligations. You are capable of evaluating, analysing and interpreting data, exercising sound judgement to draw conclusions. With a positive approach to assigned tasks and proven abilities in managing objectives to an effective conclusion, you can also demonstrate creative problem solving in a complex process-focused environment. You are able to work under pressure and you have excellent interpersonal and communication skills.
If you are proud of contributing and feel you have the commitment to teamwork and innovation that we are seeking, then Roche is the organisation for you. In return we offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation, including a genuine interest in your development and progression.
To be considered for this position, please apply using the link below.
When completing your application, please ensure you attach an up to date CV and details of your current remuneration package.
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