Job Title: PV and Regulatory assistant.

Among the common office duties, the assistant's main duties are as followed:

• Acts as a single pharmacovigilance contact point for national competent authorities on a 24-hour basis
• Liaises with the national competent authorities regarding pharmacovigilance issues for PTC products or on behalf of the marketing authorisation holder (when other than PTC)
• Has oversight over the functioning of the pharmacovigilance system (e.g. standard operating procedures, contractual agreements, database operations, compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance)
• Promotes, maintains and improves compliance with legal/regulatory requirements
• Documents and handles safety information received from any source in relation to the products under his/her responsibility, and communicates it to all stakeholders as appropriate (e.g. QPPV, principals, service providers) within the timelines defined
• Documents medical information requests received from any source in relation to the products under his/her responsibility, and communicates them to all relevant parties within the timelines defined
• Maintains awareness of the national competent authorities’ specific requirements with regards to pharmacovigilance, and informs all stakeholders as appropriate
• Reviews audit results and follows up on related action plans until full implementation

Prepares for submission:

• All license variations and renewals as per the required timelines
• Liaise with the local regulatory authorities as necessary.
• Is involved in all employees’ training on Pharmacovigilance.
• Files all Regulatory records appropriately.