Dr. Palina Tsytsik

Acting as an expert for aggregate safety reports and product specifics for BioTherapeutics, BioSurgery products and Vaccines; overseeing and reviewing work of other writers; prioritizing the work of the team, allocating tasks and activities; liaison, communication and relationship building with other groups, serving as the team representative on cross-functional project teams.

In addition to the duties and responsibilities of the Medical Safety Writer, assisting in the training of junior team members, providing functional expertise and guidance, assisting with creation and maintenance of standardized departmental procedures, leading or participating in project teams and committees as assigned; preparing or assisting in preparation of responses to regulatory authority requests.

Responsible for preparation of periodic safety reports (PSURs, PBRERs, Addenda to Clinical Overviews, DSURs) with the focus on haemophilia products, biotherapeutics and vaccines; working closely with Regulatory Affairs, Clinical/Medical affairs, Quality, IT; collecting necessary information, leading constructive discussions, making sure that all agreements are met and facilitating on time submission of the reports to competent authorities.