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Senior Pharmacovigilance Coordinator, Case Processing

1+ years
Not Disclosed
11 May 10, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Overview: For the past 20 years, ProPharma has been dedicated to improving the health and wellness of patients by offering advice 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 via an advise-build-operate model. With expertise in regulatory sciences, clinical research, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma provides fully customizable consulting solutions to de-risk and accelerate drug and device programs.

Job Summary: The Senior Pharmacovigilance (PV) Coordinator, Case Processing supports PV Coordinator staff in entering cases into the safety database. They manage assigned mailboxes, triage client communications, and maintain quality standards. The Senior PV Coordinator oversees team workload and client deliverables, ensuring goals are met. Strong communication, computer, organization, and teamwork skills are essential.

Essential Functions:

  • Manage assigned mailboxes, triage client communication, and process internal case processing communications.
  • Perform Duplicate searches and complete initial book-in.
  • Screen and redact source documents for PHI.
  • Facilitate literature-related activities.
  • Conduct initial triage of regulatory authority database searches.
  • Send draft reports to clients for review.
  • Enter basic data into safety database and perform full data entry as required.
  • Oversee team workload and client deliverables to ensure goals are met.

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 a team.

Educational Requirements: Post-secondary education.

Experience Requirements:

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

Diversity Statement: ProPharma Group is committed to diversity, equity, and inclusion, creating a workplace where employees can be their authentic selves. They encourage innovation, collaboration, and entrepreneurship, providing a safe space for all employees to succeed.

Note: ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Join their Talent Community for potential future opportunities.