Drug Safety Physician

Role & responsibilities

Contributing (authoring and/or medical review) to aggregate reports like Periodic Safety

Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs),

Development Safety Update Reports (DSURs), Addendum to Clinical Overview (ACO),

Internal Periodic Safety Review (IPSR), Risk Management Plans (RMPs)] or other scheduled or unscheduled reports, as required

• Medical review of ICSRs for marketed and investigational human and veterinary products, ensuring accurate capture of safety data within patient narratives and critical data fields which impact medical evaluation (i.e. seriousness, causality, expectedness assessment, MedDRA coding)

Preferred candidate profile

MBBS / MD - Must have experience of 3-5 years for medical review of ICSRs primarily

Location : Remote

Email : [email removed]