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Manager/Senior Manager - Pharmacovigilance

5-7 years
Not Disclosed
10 Jan. 29, 2025
Job Description
Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates 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

Job Title: Manager/Senior Manager - Pharmacovigilance
Location: Gurgaon, Haryana, India
Category: Research & Development
Job Type: Full-Time, Regular
Job ID: R-78777

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work worldwide to discover and deliver life-changing medicines, improve disease management, and contribute to our communities through philanthropy and volunteerism. We strive to give our best effort, putting people first. We are looking for individuals determined to make life better for people everywhere.

Job Summary:

We are seeking a highly skilled Manager/Senior Manager - Pharmacovigilance to oversee and manage pharmacovigilance activities across India, Bangladesh, Nepal, and Sri Lanka. The ideal candidate will ensure compliance with regulatory requirements, manage safety data, and maintain the highest standards of drug safety.

Key Responsibilities:

  • Oversee pharmacovigilance activities and ensure compliance with both local and international regulations.
  • Manage the collection, assessment, and reporting of Adverse Drug Reactions (ADRs) and other safety data.
  • Develop, implement, and ensure adherence to pharmacovigilance processes and procedures.
  • Lead, mentor, and manage a team of pharmacovigilance professionals.
  • Collaborate with cross-functional teams, including clinical, regulatory, and quality assurance departments.
  • Prepare and submit Periodic Safety Update Reports (PSURs) and other regulatory documents.
  • Conduct risk assessments and develop risk management plans for products.
  • Stay updated with the latest pharmacovigilance regulations, guidelines, and industry trends.
  • Liaise with regulatory authorities and external stakeholders when required.

Qualifications:

  • Education: Bachelor's degree in Pharmacy, Medicine, or a related field (advanced degree preferred).
  • Experience: Minimum of 5-7 years in pharmacovigilance, with at least 2 years in a managerial role.
  • In-depth knowledge of pharmacovigilance regulations and guidelines in India, Bangladesh, Nepal, and Sri Lanka.
  • Strong leadership and team management skills.
  • Excellent communication and interpersonal skills.
  • Ability to work effectively in a multicultural environment.
  • Proficiency in pharmacovigilance databases and software.

Preferred Skills:

  • Experience handling pharmacovigilance activities across multiple countries.
  • Certification in pharmacovigilance or related fields.
  • Strong analytical and problem-solving abilities.
  • Ability to manage multiple projects and deadlines effectively.

Benefits:

  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Collaborative and inclusive work environment.

Lilly is committed to ensuring individuals with disabilities have equal opportunities to engage in the workforce. If you require assistance in submitting a resume, please complete the accommodation request form here.

Lilly does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

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