Ergomed
pharmaceutical and biotechnology
PharmacovigilancePhysician/II
“Pharmacovigilance Physician / II at Ergomed. Skills: Pharmacovigilance, signal detection, medical causality assessment. review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues”
Industry & Context.
Evaluating and categorizing possible signals and proposing a course of action
Fluent in Japanese, 1 year fixed term contract
What They're Looking For.
Must Have
medically qualified as a physician, Previous experience in pharmacovigilance, Ability to review different aggregate report types including PBRERs and DSURs, Expertise in signal detection activities is essential, English - advanced (spoken, written), Japanese - advanced (spoken, written)
Nice to Have
Advanced literacy (MS Office)
What You'll Do.
review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment
act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues
review and provide input in Periodic Safety Update Reports
Development Safety Update Reports
literature screening search strategy
review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings
cooperate in the preparation of and provide input in Risk Management Plans
Supporting the preparation of responses to regulatory authority requests
Reviewing line listings
Participating in signal detection activities including meetings
writing signal detection reports if applicable if required
and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation
Evaluating and categorizing possible signals and proposing a course of action
Supporting preparation and review of benefit-risk reports
How You'll Work.
Team & Collaboration
Ability to work effectively cross-culturally and cross-functionally; Collaborative Partnerships
Communication Scope
Communication skills; Presentation skills
Process & Methodology
Ability to plan, organise, prioritise and execute multiple tasks
Applying for this Pharmacovigilance Physician / II role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on SmartRecruiters
- SmartRecruiters often includes a video screening step — check camera and mic permissions.
- Link your GitHub or portfolio directly in the profile section for technical roles.
- Applications may be reviewed by AI scoring before reaching a recruiter — use keywords from the job description.
ANONYMOUS · UNFILTERED
What do employees actually say about Ergomed?
Real rants from real employees. Read before you apply.