- Manages the local pharmacovigilance, medical device vigilance, and cosmetovigilance activities of the company.
- Reviews all incoming complaints and information requests and ensures compliant collection, data entry, routing, and follow-up of individual case reports.
- Creates case narratives and codes adverse events in MedDRA.
- Performs quality control activities to ensure complete and accurate case processing.
- Reviews cases for listedness and submits reportable cases to FDA.
- Prepares periodic safety reports.
- Provides safety training for employees and contractors.
- Develops and updates vigilance SOPs and forms.
- Monitors regulatory development in vigilances activities for marketed products.
- Ensures Good Vigilance Practices and be able to identify, implement and monitor corrective and preventive actions if necessary.
- Rigour, analysis and synthesis capabilities.
- Knowledge of medical and drug terminologies is required.
- Reactivity and ability to alert, in a timely manner, CVD/CCD and other functions on vigilance issues/alerts which occur at the national level.
- Knowledge of MS Word, Excel, PowerPoint and Outlook.
- Must be detail oriented and have strong organizational, problem solving and analytical skills.
- Strong communication skills, both verbal and written.
- Ability to develop and articulate ideas.
- Ability to juggle multiple priorities and a team player.