Job ID REQ-10006898 Sep 16, 2024 Spain Summary 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.
Provides 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.
About the RoleThe Senior Manager Aggregate Reporting and Risk Management - RMP, liaises within the team and with the Global Product Safety Leader (GPSL) to ensure alignment synergies between Periodic Safety Update Report (PSUR), Development Safety Update Report (DSUR) and Risk Management Plans (RMP).
Initiates the tracking of commitments and liaises with relevant functions that maintain and monitor the commitments.Your key responsibilities include: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 design a robust worldwide implementation plan of the RMP strategy, including for new submissions and innovative medicines, by navigating complex stakeholder matrixes.Lead initiatives related to 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, working 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 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 AR RM team as RMP expert.Deputize for the Team Lead or Group Head ARRM in defined meetings and initiatives.Experience/Professional requirement:At least 7 years in a pharmaceutical company, preferably in drug safety, clinical research, or regulatory affairs, with 3 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 of worldwide regulatory requirements for drug registration (scientific and technical aspects) and clinical drug development.Proven ability to interpret and discuss efficacy and safety data relating to multiple therapeutic areas to the level required for delivering successful RMPs and aggregate safety reports.Solid Medical/Scientific writing and verbal skills.Languages: Fluent in spoken and written English.
Understanding in another major language (e.g.
French, German, Spanish) desirable.Education:(minimum/desirable): Scientific Degree required.
Advanced degree (Masters, PharmD or PhD) desirable.Why Novartis?Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.Commitment to Diversity Inclusion:Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.Accessibility and accommodation:Novartis is committed to working with and providing reasonable accommodation to all individuals.
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Job ID REQ-10006898 #J-18808-Ljbffr
