Safety Scientist (ROCHJP00002143) (m/f)

REFERENZNUMMER:

357023/11

IHRE AUFGABEN:

-Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and highlighting and tracking potential issues
-Support the preparation and maintenance of Risk Management plans
-Prepare and review periodic safety reports (PBRER / PSUR, DSUR, EU renewal and other Annual Safety Reports) in accordance with regulatory requirements and standard operating procedures
-Support the preparation and maintenance of safety sections of the Company Core Data Sheet
-Lead/support PDS post-marketing safety study activities
-Carry out medical review of individual case safety reports (ICSRs), if assigned for the product according to SOPs and guidelines

IHRE QUALIFIKATIONEN:

-Prior industry experience in drug safety, clinical development or medical affairs is desirable
-PhD, PharmD, Pharm. MS or equivalent qualification
-Good knowledge of pharmacovigilance practices
-Strong knowledge of international drug regulation including GCP, GVP and GMP
-Good knowledge of US and EU pharmacovigilance regulatory requirements
-Excellent written and verbal communication skills and ability to present and critically discuss clinical data in both internal and external discussions
-Ability to evaluate, interpret and synthesize scientific data (analytical thinking)

WEITERE QUALIFIKATIONEN:

Drug safety manager