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Senior Risk Manager PVE-MSS - 18 Months - Biotechnology

Employer
i Pharm Consulting Ltd
Location
Huntingdon, UK
Salary
Competitive
Closing date
May 20, 2019

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Job Role
Risk Manager
Sector
Finance
Contract Type
Permanent
Hours
Full Time
JOB TITLE Senior Manager, Risk Management (RM), PVE-MSS - 18 Months - Biotechnology THE COMPANY One of the top Pharmaceutical companies in the world. The organisationis seeking a full-time contract position based in their Brussels Office. LOCATION Cambridge, UK SALARY Competitive ROLE/DESCRIPTION Signal detection and authorship of signal work-up documents in collaboration with a Medical Safety Science Medical Evaluation (MSS-ME) team member Authorship of Company Core Data Sheet (CCDS) sections and associated supporting documentation Authorship of aggregate safety reports (e.g. PSURs) Authorship of risk management plans Authorship of responses to regulatory agency safety enquiries Contributes to safety analyses in Regulatory submissions (e.g., Marketing Authorisation Application (MAAs), New Drug Application (NDAs)) Reviews global literature for identification of potential safety concerns Performs safety review of clinical trial protocols, investigator brochures, study reports, informed consent forms, and other study related documents for assigned studies Reviews standard reference documents in collaboration with a MSS-ME team member Essential Duties and Job Functions Works and leads projects with minimal supervision following established procedures Demonstrates ability to present results and findings and discuss processes in formal settings with consideration of the impact on processes within and external to PVE Demonstrates ability to analyze and resolve complex problems collaboratively with cross-functional staff Recognized within the job family as a technical expert Independently searches drug safety and literature databases for relevant information Collaborates with partner companies on safety evaluation for co-licensed products with some supervision as needed Makes good contributions to safety committee meeting discussions (internal or with partner companies) Participates on and may lead various cross-functional teams involving interaction with Gilead staff within and external to PVE Maintains a successful track record of developing contacts within PVE and across the company and using those contacts to manage projects more effectively Demonstrates the ability to work effectively with MSS-ME, other members of PVE, and colleagues external to PVE May participate in drug safety audits or inspections May manage direct reports with responsibility for employee performance evaluations May act as a mentor to junior employees KEY SKILLS Moderate level (4 years) of experience in drug safety is preferred Demonstrates proficiency in verbal and written communication, including Microsoft Excel, Office, Word, and PowerPoint Demonstrates good project management skills, excellent attention to detail, teamwork and initiative; maintains confidentiality; maintains meticulous attention to project deadlines Demonstrates ability to assess complex data sets and understand the safety/medical implications Communicates effectively to ensure relevant parties are fully informed and knowledgeable of project activities and their status Possesses good knowledge of pharmacovigilance, regulations, aggregate safety reports, risk management plans, signal detection, clinical trials, and clinical development ABOUT i-PHARM CONSULTING i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics. www.i-pharmconsulting.com TO APPLY: If you would like to discuss this vacancy further, please call the Global Strategic Delivery Consultant Billy Twomey on 44 (0)2031890460 or 31 (0) 208081504 or email at . If this role is not suitable, Billy is also available to discuss other possible positions or answer any general questions regarding your career and the current market. KEY WORDS Quality Assurance / QA / Quality Assurance Specialist / Biopharmaceutical / Dun Laoghaire / Contract / Pharmaceuticals / Pharma / Ireland / This job was originally posted as www.totaljobs.com/job/86464787

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