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17 days old

Medical Safety Officer, Immunology

Kelly Services
Titusville, NJ 08560
Kelly Science & Clinical is currently seeking a **Medical Safety Officer, Immunology** 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.


Please send your resume to Alicia Cali at alic019@kellyservices or call 216.256.7768


**Position Summary:**

The Director, Medical Safety Officer (MSO) has accountability for assessing the medical safety of assigned products and will strategically lead cross-functional teams responsible for product safety and benefit-risk oversight and represents Global Medical Safety (GMS) as a product spokesperson regarding overall benefit/risk.


The MSO will report to the Therapeutic Area (TA) Safety Head for Immunology and lead all aspects of the safety and benefit/risk assessment of assigned pharmaceutical products that are marketed and/or in clinical development within the Immunology TA. Collaborating with relevant functions, the MSO will ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles of their products relative to their potential benefit to patients. The MSO will be the primary point of contact for safety concerning his/her assigned products and clinical programs and will communicate potential and known risks and changes to benefit/risk, when appropriate, to the TA Safety Head, the Head of Global Safety Strategy & Risk Management (GSSRM), the Chief Safety Officer (CSO), the Pharmaceuticals Chief Medical Officer (CMO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities (HA), Prescribers and/or Patients.

This role requires leadership of cross-functional Safety Management Teams (SMT) for assigned products or clinical programs, with key responsibilities including, but not limited to, signal detection, benefit/risk assessment, and risk management activities (e.g., label updates, urgent safety measures). Other responsibilities include participating in strategic planning of clinical protocols and development programs and patient-centered decision-making, as well as ownership of aggregate reports (PBRER/PSUR). The Medical Safety Officer will present (either orally or in writing) the Company's scientific position with regard to safety in support of regulatory filings or response to Health Authority requests. The MSO will be an integral member of due diligence teams and have a seat at the table for go/no-go decisions on Licensing and Acquisition opportunities within the Immunology portfolio.

This role relies upon strong foundational knowledge in medicine as well as the ability to engage, influence, and mobilize teams.


**Qualifications**

Physician (MD or equivalent) with 6-9 years related experience as defined by the following:

Requires at least 2-5 years of pharmacovigilance experience or other relevant experience (e.g. Clinical research in the pharmaceutical industry or academic setting)

Demonstrated skills in clinical medicine with at least 4 years of clinical practice experience, which includes a residency program or equivalent)

Board Certification (if the US) preferred

Basic knowledge of drug development, pharmacology, clinical trial methodology, and design, and assessment of drug benefits vs. risks is a must. Knowledge of biostatistics and epidemiology is preferred

Experience with structured benefit-risk frameworks (e.g. BRAT, FDA) and current regulatory policy on benefit-risk assessment and patient-focused drug development is a plus.

Ability to influence, negotiate and communicate with both internal and external stakeholders

Experience with formal Health Authority presentations is preferred.

Ability to see the context of the entire situation, understand implications to the business.

Ability to critically evaluate safety data from multiple sources (clinical trials, post-marketing, and literature, etc.)

Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in the US, the EU, and globally, the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents, and risk management plans

Excellent writing skills as evidenced by publication and journal articles also desirable

Proficiency in Word and PowerPoint is desired


**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)
Posted: 2021-11-19 Expires: 2022-01-06

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Medical Safety Officer, Immunology

Kelly Services
Titusville, NJ 08560

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