Descrição da Vaga
This Associate Manager position is responsible for supporting the Local Safety
Officer/Regional Head to maintain the Safety activities in Latin America for
Consumer products, ensuring compliance with global, regional and local
regulatory requirements as well as company policies and procedures.
- Agreements / Contracts containing PV Language: Perform contract review and
maintain oversight to ensure safety reporting obligations are defined and
integrated into case handling procedures as necessary.
- Provide operational support to the regional safety activities related to
case translation and submission to ensure that an adequate safety system is in
- Maintain the Aggregate Reports (PSRs/PSURs) tracker for the region,
including the elaboration of local format reports and submission in Latin
America according to the regulatory requirements.
- Coordinate local safety staff activities to ensure that specified timelines
and reporting requirements are met.
- Coordinate the provision of support for third party safety agreements with
PV implications at the local level and ensure the PV agreement is implemented
locally, as appropriate.
- Provide training to J&J personnel, contractors and suppliers as required.
- Bachelor degree in Pharmacy qualification or other healthcare related degree.
- Fluent English is required and Spanish is desirable
- 6 to 8 year of experience in Pharmacovigilance/ Product Safety is preferable.
The Hiring Manager has the faculty to interview only the applicants who have
also de desirable requirements.