Job Description:
Perform collection, translation, and follow-ups of adverse events (AEs) and product quality complaints (PQCs) associated with the products.
Report to Global Pharmacovigilance (GPV) or MMD Team in a timely manner with high quality for Latin America region, except Brazil.
Support DPOC in all training-related activities.
Report suspected tampering, counterfeiting, and diversion to Global Security Group.
Oversee Local Literature Search activities.
Responsible for filing, storage, and archiving of safety-related data in accordance with MSD's policies and local requirements.
Support countries in Contract Management activities.
Oversee compliance with PV requirements in PAS (Post Authorization Studies), MSS (Marketing Support Studies), and support countries in implementing PV tasks related to these activities.
Qualifications:
Background Requirements:
- Health, life science, or veterinary medicine bachelor's degree (preferred) or equivalent by education/experience.
- Minimum 2 years of pharmaceutical industry experience.
- Awareness of Pharmacovigilance regulations within assigned country(ies), if applicable.
- Strong communication and time management skills.
Functional competencies PV Intelligence:
- Knowledge of pharmacovigilance systems & requirements.
- Knowledge of pharmacovigilance principles, concepts, practices & standards.
- Knowledge of local country(ies) pharmacovigilance regulations & obligations.
Skills:
- Excellent written & spoken Spanish and English.
- Effective verbal and written communication skills.
- Proficiency in local language(s).
- Proficiency in Good Documentation Practices.
Computer skills:
- Knowledge of safety database systems.
- Ability to learn new computer interface systems.
Personal attributes:
- Strong project management skills with the ability to prioritize.
- Excellent time management, organizational & planning skills.
- High accuracy & quality in work.
- Strong collaboration skills.
- Sense of urgency and disciplined decision-making.
- Compliance-focused mindset.
- Courage and candor.
**Note**: The section regarding the Market Security Specialist position appears to be unrelated to the PV Specialist role and can be omitted for clarity.
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