7 дней назад
Country Safety Lead (Pharmacovigilance)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Country Safety Lead (Pharmacovigilance): Leading country-level surveillance of drugs, biologics, and medical devices across clinical trials and post-marketing activities with an accent on adverse-event processing, regulatory reporting, and cross-functional oversight. Focus on managing safety operations, mentoring colleagues, implementing corrective actions, and solving complex pharmacovigilance and data-management challenges.
Location: Buenos Aires, Argentina. On-site 2–3 times per week or as required by the business.
Company
develops medicines and healthcare products and supports their safe and appropriate use through evidence-based medical expertise.
What you will do
- Lead the country surveillance program for drugs, biologics, and medical devices across clinical trials and post-marketing activities.
- Oversee the intake, evaluation, processing, and reporting of individual and aggregate safety reports.
- Manage the country safety group, including recruitment, training, performance management, and development planning.
- Provide technical guidance on the corporate safety database, issue resolution, standardization, and process improvements.
- Coordinate multiple projects and cross-functional activities while managing people, technology, and financial resources.
- Analyze operations, implement corrective actions, and communicate complex concepts to support sound safety decisions.
Requirements
- Relevant degree and experience: BA/BS with at least 4 years, MBA/MS with at least 2 years, PhD/JD with any experience, associate's degree with at least 8 years, or high school diploma with at least 10 years of relevant experience.
- Experience in pharmacovigilance, data management, clinical care, or clinical or scientific research.
- Knowledge of global regulations and guidelines for drug development.
- Experience and skill in medical writing, plus a good understanding of medical terminology.
- Strong teamwork, problem-solving, and decision-making skills.
Nice to have
- Master's degree and relevant pharmaceutical industry experience.
- Experience managing direct reports and multiple priorities or projects.
- Strong analytical and organizational skills.
- Experience using generative AI tools such as ChatGPT or Microsoft Copilot, with an understanding of responsible AI practices, risk management, and ethical use.
Culture & Benefits
- Full-time employment with a focus on improving patient health and medicine safety.
- Cross-functional collaboration and knowledge sharing across the department.
- Opportunities to develop innovative process and product improvements.
- Equal employment opportunity regardless of legally protected characteristics.
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