Title: Senior Drug Safety Associate
Duration: 12 months with possible renewal
Location- PA/NJ
About ClinChoice
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.
POSITION SUMMARY:
Job Description:
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 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.
Liaison 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, SAE/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: workload and productivity monitoring activities, workload meetings, vendor meetings, monitoring quality of ICSRs
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
Processes & procedures: awareness of and input to company procedures and guidance
Completion of all assigned training on company and GMSO procedural documents relating to case processing
Completion of training relating to relevant 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
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
Mentoring & supervision: Mentoring of Case Processing (or other identified) staff, and involvement in recruitment and supervision.
Provision of on-the-job training and mentoring of Drug Safety Associates (DSA) staff
Interview participation as required
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
Personal development: 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
Key attributes:
- 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:
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 4 - 6 years’ experience in the pharmaceutical safety-related role.
Pharma Experience:
Four 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.
Required skills, abilities and competencies include:
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
ClinChoice is an Equal Opportunity Employer / Committed to Diversity