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(Senior) Group Pv Head- Safety Physician/Pv Physician

5+ years
Not Disclosed
10 Dec. 10, 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

Novartis Pharmacovigilance Qualified Delegate – Beijing, China
Innovative Medicines, Research & Development

About Novartis
At Novartis, we are committed to improving and extending lives through innovative science. Our diverse team collaborates passionately to drive breakthroughs that change patients' lives.

Role Overview
As a Qualified Delegate of the Local Qualified Person for Pharmacovigilance, you will be accountable for overseeing pre- and post-approval pharmacovigilance activities for assigned therapeutic areas/products in the Novartis Country Organization. You will ensure compliance with local and global safety regulations while actively contributing to the communication of drug safety information and risk control measures.

Key Responsibilities

  • Act as the Qualified Delegate for the Local Qualified Person in Pharmacovigilance (PV) for assigned therapeutic areas/products, ensuring compliance with local regulations and Novartis standards.
  • Oversee operational vigilance processes, including local Risk Management Plans (RMP), signal detection, PSURs, and clinical trial safety.
  • Mentor and support less experienced staff, fostering a professional network and role modeling Novartis values and behaviors.
  • Ensure the effective implementation of safety risk control measures and the timely communication of safety information within the Marketing Authorization Holders (MAHs) and regulatory authorities.
  • Review and sign-off on critical pharmacovigilance documents.
  • Lead the creation and approval of local RMPs, including China addendums, to meet regulatory requirements.
  • Collaborate with global medical safety functions to evaluate and assess safety data.
  • Conduct local safety signal detection and escalate potential signals to global safety teams.
  • Represent Pharmacovigilance in clinical teams, contributing to safety strategy and program development.
  • Provide safety leadership in Post Approval Commitment (PAC) studies, as well as trial and program-specific data safety boards.
  • Respond to inquiries from local Health Authorities (LHAs) on safety issues and ensure compliance with national pharmacovigilance regulations.
  • Set up and update local procedures to ensure alignment with global PV requirements.
  • Review safety data for clinical trials and collaborate on safety sections of contracts for CROs.
  • Support audit activities, corrective action plans, and Health Authority inspections as required.

Essential Requirements

  • Health Care Sciences Professional (e.g., Medical Doctor) or equivalent training and experience.
  • At least 5 years of experience in pharmacovigilance, or 2 years of safety/PV physician, clinical physician, or medical affairs experience.

Desirable Requirements

  • Project management skills.
  • Strong communication, negotiation, and networking abilities.
  • Familiarity with Safety Science and Medical Science.
  • Proficiency in AI technologies.
  • Fluency in written and spoken English and local language.

Why Novartis?
At Novartis, we create a collaborative, inclusive, and empowering environment where talented individuals can grow, innovate, and make a meaningful impact on patient lives.

Commitment to Diversity & Inclusion
Novartis is an Equal Opportunity Employer dedicated to fostering a diverse workforce. We encourage all qualified individuals to apply, regardless of race, gender, or background.

Join Our Novartis Network
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Benefits and Rewards
Explore our Benefits Handbook for more information on how we support your personal and professional growth.

Accessibility and Accommodation
Novartis is committed to providing reasonable accommodations for individuals with disabilities during the recruitment process. Please email diversityandincl.china@novartis.com if you require assistance.