Scientist Job

Yoh has a contract opportunity for SCIENTIST to join our client in South San Francisco, CA.

JOB RESPONSIBILITIES:

- Developing PV plans for planned or ongoing clinical studies.
- Working closely with project and study teams to ensure that PV needs are addressed.
- Maintaining a comprehensive safety signalling program for delegated products.
- Developing, implementing, and maintaining pre- approval product-specific integrated safety management plans.
- Assisting with the development and critical review of various product documents (eg, investigator brochures, protocols, development core safety information).
- Serving as product safety expert on assigned teams (eg development subteam), provide input for Drug Safety Monitoring Board as needed.
- Performing medical review of important individual case safety reports.
- Analyzing aggregate safety data for periodic report preparation (eg EU annual safety reports), internal clinical safety review, and preparation of ad hoc reports such as regulatory authority response documents.
- Tracking and trending safety issues and maintaining appropriate documentation of monitoring activities and findings.
- Ability to provide critical and timely clinical safety parts of Clinical Development Plan.
- Facilitates the transition of appropriate drug candidates from exploratory to confirmatory development for all aspects pertinent to safety.

JOB QUALIFICATIONS:

- Excellent interpersonal skills and communication skills, including oral presentation and technical manuscript writing.
- Competence with technology applications including computer and IT skills.
- Ability to work effectively as an individual contributor and as project team member; collaborative spirit
- Thorough understanding of the regulatory environment for PV, with working knowledge of worldwide regulations and guidelines.
- Ability to analyze, synthesize and interpret scientific data.
- Familiarity with industry principles of drug development, pharmacology, toxicology, pharmacovigilance practices.
- MD, or equivalent degree with clinical practice experience, or candidates with other advanced degrees in biological science fields (eg, PhD, PA-C, PharmD) meeting the qualifications described.
- Experience within the pharmaceutical industry, preferably in clinical development, clinical safety is preferred; discovery or toxicology is an advantage.

DISCOVER ALL THAT'S POSSIBLE WITH YOH. APPLY NOW.

RECRUITER: Salima Hakim

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading professional staffing solutions.

Yoh, a Day and Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: SCIENTIFIC; J2W: CLINICAL

MONJOB J2WPACNW

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SFSF: LS