Operations Scientist, (Global Medical Safety Operations), GMSO

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Job description

Kelly Science & Clinical is currently hiring a **Operations Scientist, (Global Medical Safety Operations), GMSO** for a long-term engagement with one of our Global Pharma clients

*****This role is fully remote but prefers location in EST*****

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** :

+ Responsible for the case processing of adverse events reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance worldwide safety regulations and corporate policies

+ (50-60%) Case processing: completion of full case information on the database, including quality review to ensure accuracy and completeness

+ Triage of incoming cases to prioritize for daily workflow management

+ Completion of remaining case data entry (including narrative or auto-narrative), manual coding, label and approval

+ Preparation of Analysis of Similar Events

+ Perform quality review of Individual Case Safety Reports (ICSR) which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are incorporated.

+ Liaise with Global Case Receipt and/or Global Medical Safety Operations Physicians (GMSOP) staff as appropriate to clarify appropriate information required for case processing

+ Other activities relating to case processing as appropriate per case, including but not limited to:

+ Single case & end-of-study unbinding, Serious Adverse Event (SAE)/Adverse Event (AE) reconciliation, deviation memo preparation, deletion requests and approvals, review protocol updates for accuracy

+ Vendor oversight activities for assigned products

+ Product portfolio subject matter experts

+ Operational management activities for onshore teams and vendors, including but not limited to: o workload and productivity monitoring activities, workload meetings, vendor meetings, monitoring quality of ICSRs

+ (5-10%) Team leadership: close liaison with Senior Drug Safety Associate regarding process and workload management and deputizes for Manager as identified.

+ Takes the lead in team meetings and daily liaison with team members to identify and resolve processing issues

+ Assists Manager with implementation of processes, and issue management

+ Supports and deputizes for Manager as identified.

+ (5-10%) Supervising product-specific daily workload: prioritization and organization of team workload to maintain regulatory compliance and quality standards

+ Review workload to prioritize and ensure compliance with processing timeframes

+ Review regular ICSR Data Consistency reports to identify processing inconsistencies and errors

+ Monitor Aggregate Reporting Calendars to ensure cases are processed in required timelines

+ (5%) Processes & procedures: awareness of and input to company procedures and guidance

+ Completion of all assigned training on company and Global Medical Safety Operations (GMSO) procedural documents relating to case processing

+ Completion of training relating to relevant Pharmacovigilance (PV) Agreements for assigned products

+ Participate in designated activities to support revision/creation of case processing procedural documents

+ Promotion of awareness of procedural document requirements within team

+ (10%) Project work: participation in assigned projects, including inspection/audit readiness activities

+ Participation in local or global project teams, including on-time delivery of assigned responsibilities

+ Participation in inspections and audits as identified, including interviews and provision of requested data

+ Assistance in preparation or implementation of corrective/preventative actions relating to case processing

+ (5%) Mentoring & supervision: Oversight of mentoring of Case Processing (or other identified) staff, and involvement in recruitment and supervision.

+ Regular meetings with mentors in Case Processing, and completion of mentoring checklists/documents

+ Provision of the on-the-job training and mentoring of Drug Safety Associate (DSA) staff

+ Participates in candidate interviews and may assist in on boarding of new hires

+ Supervision of contractor DSAs as identified

+ Process & product expert: act as key contact or point of expertise for team members and external contacts for designated products or processes

+ Application and knowledge within single case processing context of: GMSO processes and guidelines, regulations and regulatory guidelines, contractual agreements, product-specific information and database/systems functionally.

+ Communication of questions clearly and concisely to the appropriate audience, providing possible solutions where appropriate.

+ Interaction with groups outside GMSO to improve process and assist with provision of information - determine what information is appropriate for these groups.

+ Understand the scope and interdependencies of the GMSO functional groups and apply this to decisions and approaches to problems

**REQUIRMENTS:**

**Education** :

+ Registered Nurse or Pharmacist (Certification/licensure is required e.g. RN, RPh, PharmD).

+ Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification)

+ Licensed Practical Nurse with Bachelor's degree, or with knowledge of pharmacovigilance usually exhibited by minimum 6 years' experience in pharmaceutical safety-related role

**Pharma Experience:**

+ 6 or more years of pharmaceutical industry experience is required, with experience in pharmaceutical safety related areas. Case processing experience is desired

+ Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred

**Leadership Experience:**

+ Strong leadership skills, ability to lead a team

**Required skills, abilities and competencies include:**

+ Ability to view the "big picture" and understand impact of decision taken within the team or function

+ Practical knowledge of global regulatory pharmacovigilance requirements

+ Understanding of medical terminology and ability to summarize medical information

+ Ability to follow guidelines and procedural documents (experience of working with SOPs etc. preferred)

+ Oriented to quality, attention to detail and accuracy

+ Manages own work: ability to prioritize, plan and organize work assignments, and able to work under strict timelines

+ Ability to effectively delegate work responsibilities to others

+ Ability to work both independently and in collaboration with others

+ Proactive approach/uses own initiative appropriately

+ Decision-making and problem-solving skills •

+ Flexibility and adaptability

+ Positive attitude

**Other skills:**

+ Good verbal and written communication skills

+ Good computer skills (Word, email) and familiarity with safety systems

+ Knowledge or experience with Excel, PowerPoint, Visio preferred

\#ACRP

**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 interests-it's 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, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're 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. ()