ClinChoice is a clinical CRO dedicated to offering high-quality full development service to biopharmaceutical, medical device, and consumer products clients. Our services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. ClinChoice has established major offices across US, China, Europe, India, Japan, and the Philippines with over 2,400 employees globally.
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: o Single case & end-of-study unblinding, 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
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
Supervising product-specific daily workload:
- Supports and deputizes for Manager as identified.
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
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
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
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
continuous development of personal skills whether task or competency-related. Activities may include project involvement, technical training, shadowing and/or mentoring others, soft-skill development.
Perform other related duties as required
Maintains compliance with company guidelines and HR policies
Results & Performance Driven (GLP)
Sense of Urgency (GLP)
Big Picture Orientation & Attention to Detail (GLP)
Collaboration and Teaming GLP)
Integrity & Credo Based Actions (GLP)
Expertise in operations activities including case processing (or other functional expertise).
Education and Requirements:
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
Six 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)
Good verbal and written communication skills
Good computer skills (Word, email) and familiarity with safety systems
Knowledge or experience with Excel, PowerPoint, Visio preferred
ClinChoice is an Equal Opportunity Employer / Committed to Diversity