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Manager/Sr. Manager-Pharmacovigilance

5-8+ years
Not Disclosed
10 Feb. 25, 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


About Eli Lilly:

Eli Lilly is a global leader in healthcare, headquartered in Indianapolis, Indiana. The company works to discover and deliver life-changing medicines, improve disease management, and provide support through philanthropy and volunteerism. Eli Lilly's employees are driven to make life better for people around the world by focusing on care, discovery, and collaboration.


Position Overview:

The Manager/Senior Manager of Pharmacovigilance will oversee and manage pharmacovigilance activities in India, Bangladesh, Nepal, and Sri Lanka. This individual will ensure compliance with regulatory requirements, manage safety data, and uphold the highest standards of drug safety across the region.


Key Responsibilities:

  1. Pharmacovigilance Oversight:

    • Ensure compliance with local and international pharmacovigilance regulations.

    • Oversee the collection, assessment, and reporting of adverse drug reactions (ADRs) and safety data.

    • Lead the development and implementation of pharmacovigilance processes and procedures.

  2. Team Leadership:

    • Mentor and manage a team of pharmacovigilance professionals.

    • Ensure high performance within the team and foster a culture of collaboration and growth.

  3. Collaboration:

    • Work closely with cross-functional teams, including clinical, regulatory, and quality assurance departments.

    • Collaborate with external stakeholders and regulatory authorities to ensure adherence to safety standards.

  4. Regulatory Submissions:

    • Prepare and submit periodic safety update reports (PSURs) and other necessary regulatory documents.

    • Develop risk management plans and conduct risk assessments for various drugs.

  5. Regulatory Knowledge:

    • Stay informed on the latest pharmacovigilance regulations and guidelines.

    • Manage and ensure compliance with regulatory authorities in India, Bangladesh, Nepal, and Sri Lanka.


Qualifications:

  • Required:

    • Bachelor’s degree in Pharmacy, Medicine, or related field (Advanced degree preferred).

    • Minimum 5-7 years of experience in pharmacovigilance, with at least 2 years in a managerial role.

    • Extensive knowledge of pharmacovigilance regulations in India, Bangladesh, Nepal, and Sri Lanka.

    • Strong leadership skills, with the ability to manage teams and projects.

    • Excellent communication and interpersonal skills.

    • Proficiency in pharmacovigilance databases and software.

  • Preferred:

    • Experience in handling pharmacovigilance for multiple countries.

    • Certification in pharmacovigilance or related fields.

    • Strong analytical, problem-solving, and project management skills.


Benefits:

  • Competitive salary and benefits package.

  • Opportunities for professional growth and development.

  • Collaborative and inclusive work environment.


Equal Opportunity Employer:

Lilly is committed to providing equal opportunities to individuals with disabilities. If you require accommodations to apply for a position, please submit an accommodation request form through Lilly’s career website.

Lilly does not discriminate based on age, race, religion, gender, disability, or any other legally protected status.


How to Apply:

For more details or to apply, visit Eli Lilly Careers.