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Manager/Sr. Manager-Pharmacovigilance

0-2 years
Not Disclosed
10 Feb. 11, 2025
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

Job Title: Manager/Senior Manager - Pharmacovigilance
Location: India, Bangladesh, Nepal, Sri Lanka
Category: Research & Development
Job Type: Full Time, Regular
Job ID: R-78777

Job Summary:

We are looking for an experienced Manager/Senior Manager to lead and manage pharmacovigilance activities across India, Bangladesh, Nepal, and Sri Lanka. The successful candidate will ensure compliance with local and international regulations, manage safety data, and uphold the highest standards of drug safety.

Key Responsibilities:

  • Oversee pharmacovigilance activities and ensure adherence to local and international regulations.
  • Manage the collection, evaluation, and reporting of adverse drug reactions (ADRs) and other safety data.
  • Develop and implement 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.
  • Stay updated on the latest pharmacovigilance regulations and guidelines.
  • Liaise with regulatory authorities and external stakeholders as needed.

Qualifications:

  • Education: Bachelor’s degree in Pharmacy, Medicine, or a related field; advanced degree preferred.
  • Experience: Minimum of 5-7 years of experience 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 in handling pharmacovigilance activities for multiple countries.
  • Certification in pharmacovigilance or related fields.
  • Strong analytical and problem-solving skills.
  • Ability to manage multiple projects and meet deadlines.

Benefits:

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

Equal Opportunity Statement:

Lilly is committed to ensuring equal opportunities for individuals with disabilities and encourages their active participation in the workforce. If you need accommodation to submit a resume, please complete the accommodation request form.

Lilly does not discriminate on the basis of 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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