Senior Medical Safety Physician - CSPV
soterius· Clinical Safety & Pharmacovigilance
About this role
This position is independently responsible to
- Medical Review of aggregate reports (PBRER/DSUR/PADER) and related signal
- management activities, screening scientific literature for the purpose of periodic submission as per the Regulations and SOPs.
- Contribute Medical Assessment for Aggregate Reports and HA responses for safety-related topics.
- Accountable for product Signalling data review, analysis and delivery in close collaboration with Product Leader. Ensure timely review, approval and communication of findings via governance fora.
- Contribute to content and participate in safety governance meetings and other external meetings as applicable (e.g., DMC, Adjudication Committee)
- Active and regular utilization of data review, reporting, and visualization tools and systems to support scientific activity
- Review, manage contribution of development of safety sections of regulatory documents and processes
- Assume RMP authoring ownership
- Collaboration with Safety Scientist, Medical Affairs and Regulatory counterparts
- on implementation and risk minimization measures
- Provide medical and PV oversight and input to Protocols, Investigator brochures,
- Safety summaries, Clinical study reports, Regulatory reports (periodic, ad hoc) • Generation/review of SOPs and WIs and execution of client and company SOPs
- Ensure compliance with project guidelines
- Maintain awareness of changes to/new regulations affecting PVG activities.
- Train and mentor new employees in aggregate reports writing and relevant
- pharmacovigilance activities (if required)
- To carry out necessary administrative duties required for the job.
- Other duties as assigned by management
- Builds and maintains good relationships across functional units and company
- affiliates.
Frequently Asked Questions
Is the salary disclosed for the Senior Medical Safety Physician - CSPV position at soterius?
The salary for this Senior Medical Safety Physician - CSPV role at soterius is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Is the Senior Medical Safety Physician - CSPV role at soterius full-time or part-time?
This is listed as a FULL TIME position. It is posted as a Senior Medical Safety Physician - CSPV role in the Clinical Safety & Pharmacovigilance department at soterius.
Which team or department does the Senior Medical Safety Physician - CSPV at soterius belong to?
This Senior Medical Safety Physician - CSPV position is part of the Clinical Safety & Pharmacovigilance department at soterius. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Senior Medical Safety Physician - CSPV position at soterius?
Click the "Apply Now" button on this page. You will be redirected to soterius's official application portal hosted on keka where you can submit your application directly.
When was the Senior Medical Safety Physician - CSPV job at soterius posted?
This Senior Medical Safety Physician - CSPV position at soterius was posted on Jul 30, 2026. Apply as soon as possible — early applications are often reviewed first.
Senior Medical Safety Physician - CSPV
soterius
You'll be redirected to soterius's official application page on keka.