Operations Scientist, (Global Medical Safety Operations), GMSO
Kelly Science & Clinical
Location: Titusville, New Jersey
Internal Number: US4171AL_BH3749438
Kelly Science & Clinical is currently hiring a Operations Scientist, (Global Medical Safety Operations), GMSOfor 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.
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
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
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
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
Good verbal and written communication skills
Good computer skills (Word, email) and familiarity with safety systems
Knowledge or experience with Excel, PowerPoint, Visio preferred
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.
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