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Manager, Pharmacovigilance

5+ years
Not Disclosed
10 Sept. 30, 2024
Job Description
Job Type: Remote 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

Pharmacovigilance Manager - Office-Based (60%) - Bulgaria or Poland

About ICON plc:
ICON plc is a premier global healthcare intelligence and clinical research organization dedicated to advancing clinical development. We take pride in our inclusive environment that fosters innovation and excellence. Join us in our mission to improve patients' lives through collaboration and commitment.

Our Culture:
At ICON, our people distinguish us. Our diverse teams enhance our partnership capabilities, driving us to become the partner of choice in drug development. Our ‘Own It’ culture is built on four core values: Accountability & Delivery, Collaboration, Partnership, and Integrity. If you share our vision and are as driven as we are, we invite you to be part of our dynamic and supportive environment.

Position Overview:
We are seeking a Pharmacovigilance Manager to oversee safety reporting processes and ensure compliance with regulatory requirements. You will play a key role in safeguarding patient safety by monitoring and evaluating adverse events in clinical trials.

Key Responsibilities:

  • Oversee the safety reporting process for clinical trials, ensuring timely and accurate submission of safety data to regulatory authorities.
  • Manage a growing team of approximately 5 PV professionals across global locations.
  • Collaborate with cross-functional teams to develop and implement safety management plans that adhere to global regulatory standards.
  • Analyze adverse event data to identify trends and provide strategic insights for risk mitigation.
  • Lead safety review meetings, contributing to the assessment and classification of safety signals and events.
  • Provide training and guidance to internal teams and external partners on safety reporting procedures and regulatory requirements.

Your Profile:

  • Degree in life sciences, pharmacy, or a related field; advanced degree preferred.
  • Previous experience managing a team, ideally across various global locations.
  • Strong background in pharmacovigilance, particularly in safety reporting within a clinical trial setting.
  • Knowledge of global regulatory requirements for safety reporting (e.g., FDA, EMA, ICH guidelines).
  • Experience navigating harmonization and restructuring post-merger or acquisition is a plus.
  • Excellent analytical skills to interpret complex medical data and present findings effectively.
  • Proven leadership abilities and experience collaborating with cross-functional stakeholders.

Benefits of Working at ICON:
At ICON, we believe our success relies on our people. We prioritize building a culture that rewards high performance and nurtures talent.

  • Competitive salary packages, regularly benchmarked against industry standards.
  • Annual bonuses based on performance metrics for both the company and individual.
  • Comprehensive health benefits for employees and their families.
  • Competitive retirement plans and life assurance.
  • An environment that encourages you to fulfill your sense of purpose and drive lasting change.

Commitment to Diversity:
ICON is an equal opportunity employer, committed to providing a workplace free from discrimination and harassment. We welcome applications from all qualified individuals regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

If you need reasonable accommodation due to a medical condition or disability during the application process, please let us know.

Interested in the Role?
Even if you don’t meet every requirement, we encourage you to apply. You might be the perfect fit for this role or others at ICON.

Current ICON Employees:
If you are a current employee, please click here to apply.