Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.
In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical company, with a strong scientific core.
Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 600 highly qualified specialists dedicated to realizing our ambitious targets.
Head of Medical Safety Surveillance - Job ID: CD1734
Lead the Medical Safety Surveillance team activities to ensure full compliance with Global Safety regulations, as well as set up of direct reports goals and objectives.
A key member of the Idorsia Drug Safety Committee (DSC) evaluating the safety profile of all Idorsia Investigational Medicinal Products (IMPs) to ensure that all safety signals are identified early, properly evaluated and managed.
Active member and provide safety expertise to various Idorsia committees: Protocol Review Committee (PRC), Document Review Committee (DRC) and Quality Assurance (QA) Committee.
Supervise all activities of drug safety physicians and medical safety writers.
Provide medical, strategic and pharmacovigilance guidance to all project related activities.
Analyze and manage complex medical issues, provide effective solution strategies/recommendations and contribute to risk management strategies.
Develop and implement proper signal detection activities, methodologies and strategies.
Provide leadership in cross functional submission teams and crisis management team.
Interface with internal stakeholders including Clinical Development functions, Global Quality Management as well as business partners and regulatory agencies.
As required, identify and develop contacts with external consultants and opinion leaders to facilitate scientific discussions and develop management strategies for safety issues.
Act as the lead Drug Safety Physicians for assigned Idorsia Therapeutic Area Investigational Medicinal products (IMPs).
Acts as deputy to the Head Global Drug Safety as required.
Doctor of Medicine degree with at least 10-year experience in clinical and post-marketing safety and/or clinical development in the pharmaceutical or biotechnology industry.
Broad scientific background and excellent clinical development knowledge, experience and ability to interpret clinical study safety information.
Possessing extensive medicinal product and disease knowledge based on didactic and clinical experience, with considerable additional expertise in safety surveillance and pharmacovigilance.
Proven record of Health Authority interactions
Full understanding of the Clinical trials and post-marketing adverse experience reporting systems, experience in product safety monitoring and preparation of investigational and post-marketing regulatory safety reports/documents.
Extensive knowledge of regulatory principles relative to safety surveillance.
Fluent in English (oral/written).
Knowledge of global safety regulations, Good Clinical Practice (GCP) and Pharmacovigilance compliance requirements
Excellent medical writing skills are required.
Previous experience with regulatory filing and contribution to key safety documents such as Integrated Summary Safety document, DSURs. PBRERs, Risk Management Plan, Company Core Data Sheet etc.
Good experience and knowledge with safety signal identification methodology and risk minimization measures.
Leadership experience and ability to manage and mentor direct reports are an advantage
Excellent interpersonal and communication skills.
Good organizational and planning capabilities
What Idorsia offers
Exciting opportunities for development and professional growth within our dynamic organization
A collaborative and solution oriented enviroment where you can make a difference
An innovative and open culture in a truly multicultural environment
If you are interested, please send your CV and motivation letter by email to firstname.lastname@example.org clearly stating the job title and reference of the position to which you are applying in the subject line.
Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.
Please note Idorsia operates a strictly-controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.