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15 days old

Safety Analysis Scientist

Kelly Services
Titusville, NJ 08560
Kelly Science & Clinical is currently seeking **Safety Analysis Scientists** for a long-term engagement with one of our Global Pharma clients


*****This role is fully remote*****


This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.


**Position Summary:**

The Safety Analysis Scientist (SAS) will be responsible for core safety deliverables including scheduled and ad hoc aggregate reports and will serve as report owner for assigned reports (medium to large volume, standard complexity). The SAS will have in-depth product knowledge and will support Safety Management Team (SMT) deliverables as required. Daily activities involve planning, conducting meetings, database searching, aggregate safety analysis and case level review, writing, and project management/coordination of strategic safety documents. The SAS will partner with team members, stakeholders including Medical Safety Officers (MSOs), and a vendor.


**Principal Responsibilities:**

Ensure timely, quality reports/safety analyses related to core deliverables with oversight as appropriate

Collaborate with Therapeutic Area Safety Head (TASH)/MSO/Safety Surveillance Physician (SSP) and other stakeholders on strategy development

Initiate/Conduct/Oversee searches of internal and external databases

Perform and/or lead aggregate safety analysis and case level review

Author, contribute, and coordinate the preparation of core safety deliverables

Ensure commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met

Partner with vendor to develop reports/deliverables

Provide SMT support as needed

Act as ad hoc member for assigned products as appropriate

Training/Meetings/Department initiatives

Participate in cross-functional training of relevant stakeholders

Attend departmental meetings and trainings

Participate in department and/or cross-functional initiatives


**Qualifications Required:**

Bachelors Degree in Health or Biomedical Science (6-8 years industry experience or equivalent)

Advanced Degree Preferred in Health or Biomedical Science (4-6 years industry experience or equivalent)

Clinical/Medical writing or PV experience preferred

Strong English verbal and written communication skills

Recognize potential issues and or safety issues and escalate to the attention of the report owner, line manager, or MSO

Ability to understand nature of adverse drug reactions and complex associations

High level of flexibility and ability to (re)prioritize work of oneself and others

Attention to detail and ability to analyze data in broader context

Ability to work across multiple functions and therapeutic areas

Review regulatory assessor comments/requests and accommodate/address as appropriate with guidance


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-11-12 Expires: 2021-12-13

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Safety Analysis Scientist

Kelly Services
Titusville, NJ 08560

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