Instagram
youtube
Facebook

Senior Safety Data Management Specialist

3+ years
Not Disclosed
10 Nov. 13, 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

Position Title: Senior Associate – Pharmacovigilance
Location: On-Premise
Reports To: Pharmacovigilance Manager

Why Patients Need You

Pfizer Worldwide Medical and Safety colleagues play a critical role in connecting evidence-based, medical decision support to ensure better health outcomes for patients. By providing unbiased, medically necessary expertise and addressing gaps in data, we empower healthcare decisions about the safe and appropriate use of medicines.

What You Will Achieve

As a Senior Associate, you will contribute to Pfizer's surveillance program for drugs, biologics, and medical devices. This will involve evaluating and processing adverse event reports, as well as supporting clinical trials and post-marketing activities. Your focus on meeting team targets and effective communication will ensure timely deliverables and facilitate consensus-building among teams.

Your dedication will ensure that Pfizer’s customers and patients receive the medicines they need, when they need them.

How You Will Achieve It

  • Contribute to the completion of complex projects, manage time effectively, and develop plans for individual project activities within the team.
  • Provide oversight and mentoring to team members on case handling, data extraction, and analysis.
  • Act as a subject matter expert in pharmacovigilance and collaborate with key partners regarding safety data collection and reconciliation.
  • Review and analyze safety-related reports to determine the safety profile of Pfizer's products, ensuring compliance with regulatory requirements.
  • Verify the accuracy, consistency, and compliance of processed cases and case data, particularly in special scenarios.
  • Mentor colleagues and provide guidance on pharmacovigilance or product knowledge.
  • Maintain expertise in assigned products and ensure adherence to corporate policies.
  • Track safety metrics and manage project/process management to meet deadlines.
  • Participate in internal and external safety activities as appropriate.
  • Handle case processing activities, including writing and editing narratives, determining appropriate follow-up actions, and escalating cases with specific complexities.

Qualifications

Must-Have

  • Bachelor’s Degree in Pharmacy or related field
  • 3+ years of experience in pharmacovigilance or related roles
  • Strong organizational/project management skills
  • Solid knowledge of global regulations and guidelines for drug development
  • Analytical and statistical skills
  • Ability to make independent decisions and resolve issues appropriately
  • Strong time management and organizational skills to meet regulatory compliance goals
  • Fluent in spoken and written English

Nice-to-Have

  • Master’s degree in a relevant field
  • Relevant pharmaceutical industry experience
  • Familiarity with performance metric management
  • Ability to make decisions independently in both routine and complex case processing situations

Purpose

At Pfizer, we are driven by our values of courage, joy, equity, and excellence. Our breakthrough culture is dedicated to transforming lives through innovation and collaboration.

School of Leaders

At Pfizer Turkey, we foster visionary leadership through rotations, international career opportunities, and a flexible work environment, ensuring that there are no limits to what we can accomplish to make a difference.

Flexibility

We support a flexible workplace culture that promotes work-life harmony, attracts top talent, and enables everyone to be their best working self.

Equal Employment Opportunity

Pfizer is committed to building a diverse and inclusive workforce. We celebrate diversity in all its forms, helping us to serve the diverse patients and communities around the world.