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Manager, Pharmacovigilance

5+ years
Not Disclosed
10 Nov. 18, 2024
Job Description
Job Type: Full Time 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

ICON plc is a global leader in healthcare intelligence and clinical research, dedicated to advancing patient safety and shaping the future of clinical development. We foster an inclusive and innovative environment, driven by a commitment to delivering excellence in every aspect of drug development.

At ICON, we’re driven by the passion of our people. Our diverse teams work together to help improve patients’ lives and contribute to groundbreaking solutions. If you’re as passionate about this mission as we are, join us and make a lasting impact on the industry.

We are seeking a Pharmacovigilance Manager, responsible for overseeing safety reporting processes and ensuring compliance with global regulatory standards. This role will provide leadership and strategic direction while safeguarding patient safety through careful monitoring and evaluation of adverse events in clinical trials.

What You Will Be Doing:

  • Lead and manage the safety reporting process for clinical trials, ensuring timely and accurate submission of safety data to regulatory bodies.
  • Line manage a team of approximately 5 pharmacovigilance professionals, with plans to expand as the team develops.
  • Collaborate with cross-functional teams to design and implement safety management plans while ensuring adherence to global regulatory standards.
  • Analyze adverse event data, providing insights and identifying trends to mitigate risks.
  • Lead safety review meetings and contribute to the classification of safety signals and events.
  • Provide guidance and training on safety reporting procedures to internal teams and external partners.

Your Profile:

  • Degree in life sciences, pharmacy, or a related field; advanced degree preferred.
  • Experience managing teams across global locations, with the ability to interview and assess candidates during periods of growth.
  • Extensive experience in pharmacovigilance, particularly within clinical trial settings.
  • Strong knowledge of global safety reporting regulations (FDA, EMA, ICH).
  • Ability to lead teams and collaborate with stakeholders to drive results.
  • Prior experience in restructuring and harmonization post-merger or acquisition is an asset.

Benefits of Working at ICON:

At ICON, we recognize that the quality of our people is key to our success. We offer competitive salaries and benefits, and regularly benchmark against industry standards. Our comprehensive benefits package includes:

  • Competitive salary and annual bonuses reflecting individual and company performance.
  • Health insurance options for employees and their families.
  • Competitive retirement plans to support future savings.
  • Life assurance and employee assistance programs for well-being and work-life balance.
  • Flexible country-specific benefits such as childcare vouchers, gym memberships, and health assessments.

Our Commitment to Diversity:

ICON is committed to fostering an inclusive work environment. We believe diversity drives innovation and excellence, and we are dedicated to providing an environment free from discrimination and harassment. All qualified applicants will receive equal consideration for employment, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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

Interested in the role but unsure if you meet all the requirements?

We encourage you to apply—there’s a good chance you’re exactly what we’re looking for at ICON, whether for this role or others.