Scientist - Drug Safety-Nonmd Job

SCIENTIST - DRUG SAFETY-NONMD needed for a CONTRACT opportunity with Yoh's client located in South San Francisco, CA.

The Big Picture - Top Skills You Should Possess:
- PDS enhances healthcare for patients by understanding and communicating the safety profile of Roche medicines to optimize their benefit-risk profile.
- Safety Scientists are responsible for carrying out pharmacovigilance activities on a product, or group of products, including single case processing, aggregate reporting, signal detection and evaluation of the PV database.
- Participates as a standing member in Safety Teams. Safety Teams include, as appropriate, various experts, such as safety scientists, safety operations physicians, epidemiologists, medical writers, biostatistics, safety licensing manager and others

WHAT YOU'LL BE DOING:
- Safety Scientists support Safety Science Leaders (SSLs) and are responsible for particular aspect(s) or segment(s) of the overall program.
- Safety Scientists contribute to the benefit-risk evaluation and to safety risk management. Cross-Functional Team Membership
- Participates as a standing member in core and sub-teams, including as relevant Clinical Sub-Team, Study Management Team, Joint Safety Team, etc., as these pertain to assigned molecule(s)/product(s)
- In the case of early projects, supports his/her manager and others by developing a clear understanding of the safety issues from the drug mechanism
- Contributes to Pharmacovigilance and Risk Management planning for designated products by preparation of the safety surveillance strategy and by highlighting and tracking potential safety issues
- Supports the preparation and maintenance of safety sections in Core Data Sheets
- When assigned, is responsible for the development and execution of Risk Mitigation Plan and Risk Evaluation & Mitigation Strategies risk mitigation tactics
- Carries out medical review of spontaneous case reports and Serious Adverse Event (SAE) reports from clinical trials, according to SOPs and guidelines
- Stays abreast of internal and external developments, trends and other dynamics relevant to the work of PDSS to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned business, therapeutic and disease area(s)
- Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment

What You Need to Bring to the Table:
- Demonstrates, or proven abilities to demonstrate, Roche Values & Leadership Competencies Outstanding attention-to-detail Has working knowledge of the multi-disciplinary functions involved in a company's drug development process.
- Ability to evaluate, interpret and synthesize scientificknows how to make trade-off decisions while balancing ethics and efficacy
- Works well within teams and is effective in collaborating with others internally and externally Ability to travel globally, as necessary

Bonus Points! Otherwise Known As Preferred Qualifications
- M.D. is preferred, PhD, PharmD, Pharm, MS or equivalent qualification and good clinical competence in the relevant therapeutic area may be considered
- Prior industry experience in drug safety is preferred
- Solid industry experience in clinical development or medical affairs (2 or more years)
- Good knowledge of pharmacovigilance practices
- Good knowledge of US and EU pharmacovigilance regulatory requirements

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Salima Hakim

Yoh, a DayTHIS ADDRESS IS EXCLUSIVELY FOR INDIVIDUALS WITH DISABILITIES REQUESTING APPLICATION ASSISTANCE.

J2W: SCIENTIFIC; J2W: CLINICAL

MONJOBJ2WPACNW

Ref:

SFSF: LS