Description
We are looking for a
Safety Scientist (ROCHJP) (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- 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
Your qualifications
- 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)
Skills:
- Drug safety manager