Pharmacovigilance Associate Manager

3 semanas atrás

Sao Paulo, Brasil Johnson & Johnson Tempo inteiro
At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world. When You Join Johnson & Johnson, Your Next Move Could Mean Our Next Breakthrough.
We are looking for the best talent for the position **PHARMACOVIGILANCE ASSOCIATE MANAGER **located in **São Paulo, Brazil.
**RESPONSIBILITIES**:
- Lead the pharmacovigilance team to be the business partner, taking the product's safety profile assessment to internal teams Ensure that systems and processes are available for collection (initial and follow-up), review, reporting and reconciliation of Adverse Events obtained through the following sources: spontaneous, solicited, clinical trials, data generating activities, local Regulatory Authorities (RAs) and all other potential sources.
- Accountable internally for ensuring that the local operation meets procedurally defined timelines for management of safety information and any local regulatory agency defined timeline for submission of individual reports.
- Ensuring that the local pharmacovigilance activities are managed in compliance with local regulations and company policies/procedures at a local, regional, and global level and in accordance with any pharmacovigilance agreements with third party business partners.
- Having an appropriate system of pharmacovigilance and Risk Management in place in order to assure appropriate oversight for products within its responsibility.
- Managing and coaching local pharmacovigilance staff.
- Responsible for the analysis, implementation and monitoring of measures taken by the company to minimize product risks.
- Actively participate in internal audits and inspections of good pharmacovigilance practices.
- Be the nominated pharmacovigilance person to local Health Authority.
**Qualifications**:
**QUALIFICATIONS**:
- A minimum of 6 + years pharmaceutical industry experience with at least 1 year in a PV responsibility role.
- Advanced English language is required, Spanish as a differential.
- Sound knowledge of general medicine or pharmacy and clinical practice, or relevant scientific/medical field.
- Proven ability to organize workflow activities and manage multiple critical issues.
- Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external stakeholders.
- Demonstrable knowledge of all local PV requirements and of global aspects of drug Safety.

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