Searching literature databases and screening database hits for new safety data on
medicinal products, reportable and non-reportable cases and signal detection.
Writing Periodic Safety Update Reports (PSUR) in PBRER format, Development Safety Update
Reports (DSUR), Addendum to the Clinical Overview (ACO), Periodic Adverse Drug Experience
Report (PADER), and Clinical Expert Statements.,
Publishing, distribution, archiving and submission of safety reports.
Preparation of Signal detection reports, including EVDAS screening if applicable.
Preparation of SARs (Signal Assessment Reports).
Writing Risk Management Plans (RMPs). Identifying safety concerns and providing advice
with regard to future risk minimisation activities for the entire life cycle of the product.
Reviewing the documents, checking for completeness and consistency, and evaluating the
report quality. Ensure training compliance. Train and mentor new staff.
Preparation of responses to PRAC assessment reports and other Authority requests (e.g.,
referrals, etc). Collaborate with internal and external stakeholders to clarify expectations and
ensuring compliance with regulatory requirements
The employee agrees to take over primary listed tasks and responsibilities in other service lines, project management activities as client contact point and additional reasonable tasks that align with their abilities, qualification and training, if required.

Assistant manager