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Safety Administrator

2+ years
Not Disclosed
10 Dec. 11, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Project Coordinator – Literature Team
Location: Office-based
Work Schedule: Standard (Mon-Fri)
Posted: 12/11/2024

Position Overview:

We are seeking a Project Coordinator to join our Literature Team. In this role, you will coordinate the timely review of adverse events, track necessary data, and generate reports for clients, project teams, and external vendors. You will also act as a representative at literature-related meetings, ensuring smooth project coordination, adherence to budgets, and maintaining audit readiness.

Key Responsibilities:

  • Adverse Event Review: Coordinate the timely review of serious and non-serious adverse events, ensuring accurate tracking and reporting to clients and vendors.
  • Client & Vendor Relations: Represent the Literature Team in meetings with clients, third-party vendors, and internal teams. Coordinate logistics and assist with meeting facilitation.
  • Project Management: Interface with internal and external stakeholders to ensure smooth project implementation. Review contracts for accuracy and manage internal/external approvals.
  • Meeting Coordination: Coordinate project meetings, draft minutes, post materials to client portals, and distribute to relevant parties.
  • Training & Audits: Manage project-specific training, maintain program files, and ensure audit readiness for pharmacovigilance (PV) processes.
  • Data Privacy & Compliance: Identify and redact subject identifiers as required, retrain staff, and escalate issues to the Data Privacy team.
  • System Management: Perform data entry and reconciliation in databases, tracking systems, and budget management systems, identifying issues that may impact timelines.
  • Expense Management: Oversee project expenses, manage translations, and ensure literature procurement stays within budget parameters.
  • Junior Staff Training: Provide training and mentorship to junior team members.

Requirements:

  • Proven experience in project coordination or related field.
  • Strong organizational, communication, and problem-solving skills.
  • Knowledge of pharmacovigilance, adverse event reporting, and project management.
  • Ability to work in a fast-paced environment, managing multiple priorities effectively.
  • Proficient in data entry, budget management, and system reconciliations.
  • Ability to liaise effectively with clients, vendors, and internal teams.
  • Detail-oriented with a focus on compliance and audit readiness.

Why Join Us?

Join our dynamic team and contribute to delivering high-quality services in the pharmaceutical industry. We offer a supportive environment where you can grow your skills and advance your career.

Apply Now:

To apply, visit our career page or email careers@company.com.