Pharmacoviglacne Scientist

A well-known global pharmaceutical company with leading products across various therapeutic areas is looking to hire an experienced Pharmacovigilance (PV) Scientist to join our Patient Safety department, to work in the Oncology Therapeutic Area. This vacancy is an exciting opportunity to work at a top global pharmaceutical company that has a workforce of more than 6,700 employees across multiple sites in the UK.

This role will work collaboratively with the Global Safety Physician (GSP) and other PV Scientists in reviewing, analysing and interpreting safety data obtained from patients who have been administered the assigned company medicinal products. As the PV Scientist, you will apply your strong pharmacovigilance and scientific background, knowledge, and skills in authoring and / or providing input to safety-related documents, including regulatory periodic reports. You will be involved in setting the safety strategy for aggregation, analysis and interpretation of safety-related information for the assigned drug development programmes. You will be working with a team of Patient Safety experts (physicians, other scientists) and collaborating with colleagues from across the company and externally, including counterparts within Clinical Project Teams, Global Regulatory Affairs, Global Commercial and/or Investigative Medicines teams.

Job Responsibilities

• Conducts / leads the proactive pharmacovigilance, with safety signal detection, reviews, evaluation and labelling activities for assigned products.
• Presents issues to the governance committees (including the Safety Information Review Committee (SIRC) and has the capacity to take the lead role in data evaluation and discussion of the safety information with the SIRC Chairperson, the Global Safety Physician and other key stakeholders.
• Produces accurate, concise, comprehensive and fit for purpose initial drafts of safety-related responses to queries raised by various stakeholders / customers, e.g. regulatory authorities, with clear evidence-based assessments, discussions, conclusions and agreed recommendations where required / applicable.
• Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, the published literature and other information sources in order to establish the safety profile of assigned medicinal products, and consequently inform on how best to manage the risk to patients.
• Involvement in risk management planning for assigned products, in partnership with the Patient Safety Physicians and others as appropriate. This would include preparation of safety aspects of risk management plans, characterisation of risks, proposals for mitigation/minimisation measures, contributions to the safety-related submission strategies, and definition of the risk component of the benefit/risk assessments.
• Authors/provides strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
• Authors/provides input to regulatory submissions for new products, formulations or indications
• (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
• Other PV Scientist duties and responsibilities (e.g. training, process improvements, etc) as may be assigned from time to time.

Skills and Requirements:

• Degree in life-sciences (e.g. pharmacy, nursing, medicine, bio-medical science), with proven relevant / related work experience post-qualification.
• Fluent in written and spoken English.
• High level of scientific competence, with an ability to balance this with industry standards to achieve business goals.
• Experience in pharmacovigilance within the pharmaceutical industry setting, with clear evidence of delivery.
• Strong planning and organisational skills, and the ability to manage multiple priorities, tasks or goals.
• Desirable
• Post-graduate qualification (e.g. MSc, PhD) in a related scientific discipline (e.g. MSc in Pharmacovigilance).
• Safety / Pharmacovigilance experience in early phases of clinical development. Although experience in the oncology therapy area is desirable, a demonstrable ability to work across therapeutic areas or cross-functions would be an added advantage.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Jon Stewart on +44 203 7520 318 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.