Johnson & Johnson Careers
Gerente Associado – Medical Safety
São Paulo, Brazil
Requisition ID: 5402181008
The Associate Manager for Medical Safety (AMMS) reports into the Medical Safety Organization and supports the Regional Medical Safety Officer for LATAM Region who owns the post-marketing safety surveillance and risk management recommendations for the portfolio of Consumer products in the region and allocated products of local responsibility (POLO). The AMMS also supports RMSO-related activities including provision of medical safety
expert inputs into product developments within the region, aggregate safety data assessments, medical safety input into product labelling, collaboration with matrix teams from other J&J functions and licensing partners on the medical safety assessments/healthhazard evaluations of GMP quality issues with potential impact on their safe use.
The AMMS also works in collaboration with the MSO(s) who have global responsibilities for a therapy area to
support the development of the medical safety strategies and support oversight for the execution of the risk management and pharmacovigilance activities for all products, including new product developments in a region.
- Provide support in the collaboration activities (e.g., Medical Safety inputs and opinions on safety issues, Health Hazard Evaluations / Medical Safety Assessments, Medical Safety position in QRBs) with MSOs, RMSOs, Regulatory Affairs and Quality Assurance and Compliance for management of regulatory
authoritiy inquiries, GMP events and observed trends of AEs with potential impact on safety of marketed products in the region and POLOs.
- Provide input into product development process and contribute to the design and interpretation of
Clinical Investigations and non-Clinical Safety Studies for POLOs and regional products.
.Medical Doctor (MD) or Bachelor’s Degree in Health Sciences ( Biology, Pharmacy, Biomedicine, Nursing, Odontology etc)
. 3+ years of relevant experience, preferably in the pharmaceutical industry, is required (Medical, Regulatory or Safety Departments preferred).
. Strong written and verbal communication skills are required.
. Able to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc), and communicate and align stakeholders to safety decisions.
. Ability to facilitate decision making in collaboration with others.
. Advanced English.
Brazil-São Paulo-São Paulo
J&J do Brasil Indústria e Comércio de Produtos para Saúde Ltda. (7600)