Monitors and audits the company's drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling. Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing.
About the RoleThe Global Risk Management Plan Lead guides the Safety Lead and the SMT/GPT on Good Pharmacovigilance Practices and other regulatory and internal requirements for Safety Risk management, including strategic support to new submissions and innovative products. You will also provide support to the Safety Lead in the management, coordination, development, reviewing, and tracking of Safety Risk Management Plans (RMP) to ensure that documents are of high quality, regulatory compliant, and that logistics and distribution are handled in an appropriate and timely manner.
Your key responsibilities, but not limited to; Drive the development of a robust and feasible RMP strategy aligned with the benefit-risk profile of the product, together with the Safety Lead and the SMT/GPT, including for new submissions and innovative medicines, aligned with business priorities.Guide strategic decisions and designing a robust worldwide implementation plan of the RMP strategy, including for new submissions and innovative medicines, by navigating complex stakeholder matrixes.Lead initiatives related with Good Pharmacovigilance Practices and other regulatory and internal requirements for Safety Risk management, as well as company and industry practices.Represent the RM function in the Safety management team, works in close collaboration with the Safety Lead, Regulatory and other team members of the SMT/GPT (Clinical, Medical Affairs, Epidemiology, Biostatistics, Clinical Pharmacology, and Marketing, etc.) for the risk minimization activities planning and defining of effectiveness, including for new submissions and innovative medicines.Partner with the commercial team to integrate RMP requirements in marketing launch activities, as well as in communications to COs.Mentor new hires in the RMP team as RMP expert.Deputize for the Global RMP Group Head in defined meetings and initiatives.At least 8 years in a pharmaceutical company, preferably indrug safety, clinical research, or regulatory affairs, with 4 or more years expert knowledge in safety risk management.Proven ability to work with large cross-functional teams in complex projects, including new submissions and innovative medicines. Has demonstrated teamwork and effective communication skills. Partners with other line functions and establishes effective relationships with stakeholders at all levels.Knowledge in worldwide regulatory requirements for drug registration (scientific and technical aspects) and clinical drug development.Proven ability to interpret, discuss efficacy and safety data relating to multiple therapeutic area.Solid Medical/Scientific writing and verbal skills.Educational Background: Scientific Degree required. Advanced degree (Masters, PharmD or PhD) desirable.
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Division Development
Business Unit Innovative Medicines
Location Spain
Site Barcelona Gran Vía
Company / Legal Entity ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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