Job Overview

The Project Lead – Pharmacovigilance position at DDReg presents an exciting opportunity to elevate your career in pharmacovigilance project management. As a vital member of our Project Management team, you will be the primary contact for clients, guiding project activities, and ensuring that projects are not only delivered on time and within scope, but also uphold the highest quality standards. Embrace this chance to make a meaningful impact in the field!

Key Accountabilities:

Providing oversight and direction for all pharmacovigilance services.

Client Relations:

• Acting as the primary liaison for clients and project teams.
• Serve as the primary contact, maintaining excellent communication and relationships with clients and internal teams.
• Ensure consistently high-quality work and client satisfaction through clear communication, regular updates, and proactive problem-solving.

Project Management:

• Develop project scope and objectives based on signed agreements, ensuring alignment with client needs and regulatory requirements.
• Plan and track project activities, ensuring deadlines and interim milestones are met. Provide regular updates to clients and management on project status.
• Coordinating with the project manager and cross-functional project resources.
• Assessing workload and coordinating with resource managers for planning.
• Supporting pharmacovigilance project setup and team training.
• Representing pharmacovigilance in client and project team meetings.
• Conducting team briefing meetings to ensure project understanding and communication.
• Ensuring delivery of high-quality pharmacovigilance work within agreed timelines.
• Monitoring quality and compliance for safety deliverables.
• Leading coordination of safety or medical information-related activities.
• Training and mentoring newly hired pharmacovigilance staff.
• Performing other activities as identified and requested by pharmacovigilance management.

Qualifications:

• Experience: 3-4 years of previous Pharmacovigilance Project Management experience, preferably within a service provider or CRO environment.
• A Life Science or Biomedical background with a healthcare-related degree (e.g., pharmacology, biology, biotechnology, veterinary science).

Skillset:

• Proficiency in PV processes/regulations including but not limited to 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
• Excellent client-management skills, with strong communication and presentation abilities.
• Proven time management, organization, and multitasking skills with a keen attention to detail.
• Advanced verbal and written English proficiency (minimum B2 level).
• Advanced knowledge of MS Office applications (Word, Excel, PowerPoint).