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Sr. Pv Professional

5+ years
Not Disclosed
10 Sept. 19, 2024
Job Description
Job Type: Full Time 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

Who We Are

At Teva Pharmaceuticals, we’re on a mission to make good health more affordable and accessible, helping millions around the globe lead healthier lives. This mission connects our diverse workforce across nearly 60 countries, representing a rich tapestry of nationalities and backgrounds. As a leading manufacturer of generic medicines and a proud contributor to the World Health Organization’s Essential Medicines List, our products are relied upon by at least 200 million people every day. We're continually seeking innovative ways to make a difference and welcome new team members to join us in this important work.

The Opportunity

Join us in performing case processing and related activities in alignment with Global Data Management.

How You’ll Spend Your Day

  • Manage serious and non-serious case processing for business partners, health authorities, social media, non-interventional studies, legal cases, literature, clinical trials, and patient support programs.
  • Demonstrate in-depth knowledge of various case processing conventions, achieving productivity targets in daily, monthly, and yearly outputs.
  • Handle end-to-end case processing, including intake, triage, quality checks, submissions, and resolution of E2B rejections.
  • Support major health authority audits and inspections as a presenter, ensuring all auditor requests are met with thorough quality checks.
  • Address daily clarifications for a wide range of case types, including spontaneous and solicited reports, clinical trials, and literature cases.
  • Participate in SOP reviews and contribute to changes based on ICH and GVP guidelines, serving as a mentor for CAPA and deviation writing and monitoring.
  • Conduct gap analysis and engage with multiple stakeholders for various pharmacovigilance projects.
  • Manage literature monitoring, translation requests, search strategy development, and quality checks of literature activities, including downloading source documents from health authority databases (e.g., Health Canada, EMA, MHRA).
  • Assist with data correction and cleanup projects within the safety database.
  • Mentor and train team members in case processing, conducting sessions on existing and predicted error trends to drive process improvements.
  • Analyze quality data to identify trends and implement quality improvement initiatives.

Your Experience and Qualifications

  • M.Pharm, Pharm D, or BDS in a registered life sciences discipline.
  • 5+ years of experience in pharmacovigilance case processing and related activities aligned with Global Data Management.

Teva’s Commitment to Equal Employment Opportunity

Teva Pharmaceuticals is dedicated to providing equal employment opportunities for all. Our global policy ensures that hiring practices are free from discrimination based on age, race, religion, gender, disability, sexual orientation, and other protected statuses. We strive for a diverse and inclusive workplace. If you require accommodations during the recruitment process, please inform us, and we will treat your information confidentially to ensure an accessible candidate experience.