Специалист по фармаконадзору

В международной фармацевтической компании открыта вакансия Специалиста по фармаконадзору.

Декретная ставка с июня 2024г.

Main Responsibilities:

• Handling of all local drug safety information, including collection, registration, translation from local language into English, and transmission to GPS as applicable in a timely manner, seeking follow-up information;
• Perform required activities for obtaining PDCS approval (such as review and provide input to safety section of study/project documents, certification of programs, AE reconciliation, providing updates);
• Contribute to the preparation and submission of Periodic Safety Reports for local health authorities according to country requirements (e.g.: local appendices for PSURs, PBRERs, etc);
• Collaboration with relevant internal/external stakeholders for PV matters;
• Safety Reporting to local Health Authorities, as applicable;
• Oversight of relevant local / global clinical studies / PV relevant projects;
• Ensuring that current global PV procedures and applicable PV legislation are followed;
• Provision support for PV training activities;
• Participation in PV relevant audits/inspections;
• Monitoring of PV related legislation.

Key Requirements:

• Background in Pharmacy, Chemistry, Life sciences, Medicine or a related scientific discipline.
• Preferably at least 2 years’ experience related to Pharmaceutical industry, ideally with a mix of Pharmacovigilance / Quality Operations.
• Good command of English (both oral and written).
• Knowledge of local laws and local regulations.
• Excellent time management and communication skills.

Working conditions:

• Salary + annual bonus
• VMI policy for employees and children
• Compensation for lunch meals
• Hybrid work schedule
• Flexible start of the working day