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Senior Pharmacovigilance Coordinator, Case Processing

1-3 years
Not Disclosed
15 May 15, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Overview:

For the past two decades, ProPharma has been dedicated to enhancing the health and wellness of patients by offering guidance and expertise to biotech, medical device, and pharmaceutical organizations worldwide. As the largest Research Consulting Organization (RCO) globally, ProPharma collaborates with clients throughout the entire product lifecycle, employing an advise-build-operate model. With a focus on regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma delivers fully customizable consulting solutions to de-risk and accelerate high-profile drug and device programs.

Job Summary:

Position: Senior Pharmacovigilance (PV) Coordinator, Case Processing
Role: Assist PV Coordinator staff with case entry in the safety database, oversee client communications, and ensure quality standards.

Essential Functions:

  1. Manage assigned mailboxes, including inbox triage of client communication and internal case processing communications.
  2. Conduct duplicate searches and complete initial book-in as required.
  3. Screen and redact source documents for PHI following company procedures.
  4. Facilitate literature-related activities as necessary.
  5. Perform initial triage of regulatory authority database searches.
  6. Send draft reports to clients for review as needed.
  7. Enter basic data into safety database such as identifiable patient, report, suspect drug, and adverse event.
  8. Oversee team workload and client deliverables to ensure daily/weekly goals are met.
  9. Perform other duties as assigned.

Necessary Skills and Abilities:

  • Strong verbal, written, and interpersonal communication skills.
  • Proficient computer knowledge and keyboarding skills.
  • Strong organization and prioritization skills with attention to detail.
  • Ability to work independently and within an interdisciplinary team.

Educational Requirements:

  • Post-secondary education.

Experience Requirements:

  • Required: One year of related work experience.
  • Preferred: One year of industry experience.

Diversity, Equity, and Inclusion:

ProPharma Group celebrates diversity and is committed to creating an inclusive workplace where every individual can thrive. Employees are encouraged to embrace their unique qualities and contribute to an innovative and collaborative environment. As an Equal Opportunity Employer, ProPharma Group provides a safe space for all employees to succeed.

Note: ProPharma Group does not accept unsolicited resumes from recruiters/third parties. No phone calls or emails regarding this posting, please.