Senior Pharmacovigilance Executive
In this position you will be:
- Managing multiple projects related to pharmacovigilance (end to end).
- Processing cases in the safety database including submission of cases to health authorities.
- Maintaining and updating the Pharmacovigilance System Master file.
- Carrying out local and global bibliographic search and retrieval of full text articles to identify safety information.
- Communicating with EMA and other health authorities.
- Providing support with audit and corrective and preventative actions regarding PV activities.
- Providing support in updating the company’s PV SOP and working instructions.
- Maintaining highly organized records of all documentation relating to safety agreements, PV agreements or service agreements.
- Participating in ongoing professional training to keep skill level and knowledge up-to-date.
- Providing professional training to colleagues from various departments.
To be successful in this role you should have:
- Good understanding of EU regulatory requirements and good PV practices.
- Minimum 3 years of EU Pharmacovigilance experience.
- Excellent written and oral communication skills in English.
- Good analytical thinking.
- Project management and organizational skills.
- Flexible and adaptable to changing project priorities and work assignments.
- Ability to work independently and results orientation.
- Ability to keep timelines and deadlines.
Who we are?
ELC GROUP is a fully-fledged global regulatory partner, working with major pharmaceutical stakeholders for over a decade. Among several other services, ELC Group provides comprehensive pharmacovigilance service.
Note: all fields are required