Patient Safety Specialist - Benefit Risk Evaluation

Regulatory Affairs/Clinical Affairs Nazareth, Belgium


Descripción

For our Nazareth (Belgium) location, we are currently looking for a Patient Safety Speciaist.

Your responsibilities:

Safety Writing:

-          You will collect the required data for the authoring of Safety documents.

-          You will document, write, coordinate, review and validate periodic reports such as PBRER, RMP, ACO and other related safety documents.

-          You ensure generation, consistency, and quality of safety sections in submission documents.

-          You discuss the content and strategy of safety documents with important stakeholders within the Benefit/Risk Group and Global Regulatory Affairs.

-          You participate on writing responses or contributions  for the health authorities related safety enquiries.

-          You work with a cross functional team to realize deadlines for health authority requests and submissions.

-          Ensure that safety documents (e.g. periodic reports, signal evaluations, regulatory enquiries, risk management plans) are written accurately and in a timely manner to meet global compliance and regulatory requirements.

-          Provide support for submission of PSUR’s

-          Assist in creations of core structured benefit-risk assessments, core Risk Management Plans (RMPs), and EU RMPs.

-          Supports development of risk management plans in modular format and cross-use and reference of modules in PBRER etc.

-          Develops and maintains respective standards and calendars for PSURs

-          Contributes to cross-functional initiatives aimed to improve pharmacovigilance capabilities related to benefit -risk management

-          Supports inspection and audit activities with regards to the RM & BRE processes within Safety

-          Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor

CDS/CSI:

-             You will be safety responsible for the project  of the implementation/development/update of CDS/CSI for Omega medicines portfolio

-             You have experience in writing and management of CDS/CSI

-             You manage cumulative safety planning in accordance with timelines as mentioned into signal management procedure.

 

Literature:

-             Management of the literature review process and make sure that t is continuously aligned with the corresponding SOP.

-             Collection, management & control of countries Literature log

-             Validate periodically  the literature review criteria & key words provided by the service provider.

-             Work very closely with the literature review service provider to improve if needed the process in place

-             Ensure the systematic and continuous quality control/check of the literature review outputs

 

Your profile:

  • You hold a medical/scientific degree
  • You havd at least 1 year of experience in a similar position for medicinal products in an international context.
  • You are analytical and details oriented.
  • You are able to write safety documents.
  • You have a good knowledge of PSUR & RMP.
  • You demonstrate initiative and capacity to work under pressure.
  • You are a true team player and demonstrate leadership within cross-functional team environment.
  • You speak English fluently.