Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas’ lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 trial within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit www.calliditas.com for further information.
Pharmacovigilance (PV) Senior Safety Scientist will be responsible for executing safety activities for marketed products and products in development. The PV Senior Safety Scientist will provide scientific and technical expertise to AE reporting, safety surveillance and risk management activities; and will also contribute to oversight of safety activities performed by Contract Research Organizations (CROs). As a subject matter expert for safety processes, the PV Senior Safety Scientist will contribute to the development and maintenance of safety related processes and work instructions, periodic reports, developmental risk management plans (dRMPs), Risk Management Plans (RMPs) and other deliverables to support the business needs.
Key tasks and responsibilities
- Be the responsible safety professional for assigned products.
- Maintain knowledge of diseases for assigned programs.
- Contribute to signal detection activities, involving identification, evaluation, analysis, and interpretation of safety data for signal detection and risk assessment reports.
- Coordinate or contribute to multidisciplinary Safety Management Team (SMT) meetings whose responsibilities include signal detection and validation, signal and risk assessment and making recommendations regarding risk management, communication plan and labeling.
- Lead the delivery of key safety documents, contributing to high quality and accurate documentation relevant to drug safety outputs such as Periodic Adverse Drug Experience Reports (PADERs), Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs).
- Contribute to benefit-risk evaluations and preparation of RMPs and dRMPs for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accordance with regulatory requirements.
- Contribute to the creation and maintenance of safety sections of Reference Safety Information (RSI) such as the Investigator Brochure (IB), Company Core Data Sheet (CCDS) and product labeling.
- Contribute to high quality and timely responses to safety queries from internal colleagues and regulatory authorities.
- Provide safety expertise for Clinical Development and Medical Affairs projects and product development teams.
- Participate in inspection readiness activities, internal audits, and external inspections.
- Maintain knowledge of new PV/safety regulations and guidance from regulatory authorities.
- Develop or contribute to development of department processes including policies, SOPs and Work Instructions, and other relevant safety documentation.
- Contribute to marketing applications and regulatory queries including License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency safety responses.
- Ensure compliance with corporate policies, procedures and the company´s code of Business Conduct and Ethics.
- Take an active role as a Pharmacovigilance (PV) Senior Safety Scientist to ensure development and delivery of defined targets and initiatives in line with the company strategy.
Reports to VP Head of Pharmacovigilance
Education and experience requirements
- Bachelors, Masters or Postgraduate degree in Health Care profession, Public Health, Epidemiology or Life Science, previous experience as a health care provider preferred.
- At least 4 years of experience in the pharmaceutical industry working in pharmacovigilance, including work with periodic reports and SOP authorship.
- Strong knowledge of pharmacovigilance regulatory requirements
- Strong skills in scientific writing
- Good understanding of safety reporting and pharmacovigilance compliance
- Previous data entry of individual case safety reports in a Global Safety Database
- Familiar with Office applications such as Word, Excel and PowerPoint
- Attention to detail
- Problem-solving and decision-making skills
- Able to work collaboratively and independently
- High ethical standards
- Time management and organizational skills
Reasons to join the Calliditas Team
- Be a part of a global leader in IgA-Nephropathy and a rapidly growing clinical-stage pharmaceutical company
- Be a part of the completion of the Nefegard trial and our focus to file for marketing approval with the US FDA and EMA
- Get in on bonus and benefit programs
- Fast paced small company environment