Drug Safety Associate Job

DRUG SAFETY ASSOCIATE needed for a CONTRACT opportunity with Yoh's client located in WILMINGTON, DE.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- SAE and AE
- ARGUS

WHAT YOU'LL BE DOING:

- Review Commercial and Market Research programs to ensure adverse event reporting compliance
- Document descriptions of programs, suppliers and adverse event training
- Maintain well-documented files for process reviews and
- Initiate, track and complete investigations that may include corrective and preventative actions
- Exhibits a high level of professionalism and is self-assured in presentation skills
- Ensure compliance with global and local procedural documents and local implementation of patient safety objectives, policies, processes and procedures
- Effectively negotiate supplier contracts with legal partners in regards to adverse event reporting requirements
- Create and manage adverse event training for employees and suppliers
- Demonstrated working knowledge of FDA post marketing regulations relevant to patient safety and adverse event reporting
- Support regulatory inspections and internal audits
- Create and review compliance reports for accuracy and completeness prior to submission to internal and external sources
- Contribute to the implementation of new safety-related systems, processes and procedures within the region
- Have effective project-management skills, including the ability to manage multiple competing tasks and re-prioritization while meeting tight project timelines
- Participates in cross-functional project team meetings minimum requirements - education and experience

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelors degree in biosciences required, BA/BS degree in another major acceptable with addition of healthcare, pharmaceutical industry or procurement experience
- Minimum of one to two (1-2) year experience in pharmaceutical industry
- Demonstrate high functioning ability
- Basic competence with medical and therapeutic terminology
- Able to work independently, guided by procedures, with appropriate support
- Able to work effectively as part of a team
- An understanding of regulatory requirements around post marketing adverse event reporting
- Highly effective communication skills
- Maintains high ethical standards, including a commitment to values and behaviors
- Proficient in Microsoft Office programs
- Good attention to detail and time management skills

GET HIRED, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Contact us if you are an individual with a disability and require accommodation in the application process.

J2W: CLINICAL

TAX TERM: CON_W2

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SFSF: LS