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18 days old

Associate Director

Kelly Services
Titusville, NJ 08560
Kelly FSP is hiring a **Associate Director** to work directly with one of our major pharmaceutical clients. This role is a full-time, salaried opportunity offering our enhanced benefit package. As a Kelly employee within this group, you will be eligible for our benefit options including Medical, Dental, 401K and a variety of other benefits options to choose from. This includes paid time off, including holiday, vacation, and sick/personal time unless told otherwise. All Kelly FSP employees receive annual performance reviews.


Please send your resume to Alicia Cali at alic019@kellyservices.com or call/text at 216.256.7768


**PRINCIPAL RESPONSIBILITIES:**


The objective of this position is to provide medical expertise regarding the operational aspects of individual case medical review. The Associate Director, Global Medical Safety Operations Physician (GMSOP) has primary responsibility for determining the medical and scientific relevance of adverse event reports within the context of the products safety profile as well as other products within the same therapeutic area. These responsibilities include spontaneous reports, clinical and non-clinical studies, literature reports and other sources of safety data.


Medical Review


Non-Suspected Unexpected Serious Adverse Reaction (SUSAR) clinical


trial cases for products in development


Non-med significant Follow-up SUSARs


Partner SUSARs (where is Company does not change the Business


Partner assessment)


SUSARs for non-company sponsored trials


Spontaneous/ solicited individual case safety reports for products as


assigned


Perform aggregate review of non-serious cases in line listings


Evaluate Individual Case Safety Report (ICSRs) for potential product quality issues (including device malfunctions, if applicable).


Targeted Follow-up Questionnaires


Investigator Brochure activities as assigned


Anticipated Events activities as assigned


All other operational activities that require physician input example:


Standard Operating Procedures (SOPs),


CAPAs


Periodic Adverse Drug Experience Reports (PADERs)


**WORKING RELATIONSHIPS/INTERFACES:**


+ Medical Safety Officers - frequent. Discuss findings from ICSR review/Analysis of Similar Events (AOSE)/Designated Medical Events (DME) and/or systematic surveillance program and suggest potential safety issues for further evaluation. Provide surveillance consultation on ad hoc safety issues and queries. Participate with Medical Safety Officers on preparation of Pharmacovigilance Plans or Risk Management Plans.

+ Aggregate Reports Group - occasional. Discuss signal detection findings and suggest potential safety issues for discussion in Periodic Benefit-Risk Evaluation Report (PBRER) and other regulatory reports. Suggest potential search and analysis strategies for case series of interests.

+ Support Desk - occasional. Suggest potential search strategy to identify case series of interests. Safety Associates - frequent. Reviews the Adverse Event (AE) reports prepared by the Safety associates and amends as needed. Requests specific follow-up information on cases. Ensures that the Safety associates are kept informed of product-specific information, such as labeling changes, new protocols, or potential safety signals.

+ Safety Surveillance Physician (SSP) - frequent. Ensure bi-directional flow of product-specific information via participation in extended therapeutic team meetings, product-specific meetings, AOSE summaries, ad-hoc emails/telecons.

+ GMSOP Team Lead - frequent. Ongoing discussions of ICSRs, performance and development as well as other work-related issues.


**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: 2021-12-20

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Associate Director

Kelly Services
Titusville, NJ 08560

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