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Manager/Sr. Manager-Pharmacovigilance

5-7 years
Not Disclosed
10 Feb. 18, 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: Gurgaon, Haryana, India
Category: Research & Development
Job Type: Full-Time, Regular
Job ID: R-78777


About Eli Lilly and Company:

At Eli Lilly, we are a global leader in healthcare, dedicated to discovering and delivering life-changing medicines. We aim to improve lives, understand diseases better, and give back to our communities. If you are passionate about improving patient safety and working in a dynamic environment, we encourage you to join us.


Job Description:

Job Summary:

Eli Lilly is looking for a Manager/Senior Manager in Pharmacovigilance to oversee pharmacovigilance activities across India, Bangladesh, Nepal, and Sri Lanka. The role ensures adherence to local and international safety regulations, manages safety data, and maintains high standards of drug safety.


Key Responsibilities:

  • Regulatory Compliance & Reporting:

    • Ensure adherence to pharmacovigilance regulations for the mentioned regions.

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

    • Prepare and submit Periodic Safety Update Reports (PSURs) and other regulatory documents.

  • Team Leadership & Process Implementation:

    • Lead and mentor a team of pharmacovigilance professionals.

    • Develop and implement pharmacovigilance processes and safety reporting procedures.

  • Collaboration & Risk Management:

    • Collaborate with cross-functional teams such as clinical, regulatory, and quality assurance.

    • Conduct risk assessments and develop appropriate risk management plans.

  • Regulatory & Stakeholder Interaction:

    • 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 degrees preferred.

  • Experience:

    • A minimum of 5-7 years in pharmacovigilance, including at least 2 years in a managerial role.

    • In-depth knowledge of pharmacovigilance regulations in India, Bangladesh, Nepal, and Sri Lanka.

  • Skills:

    • Strong leadership and team management skills.

    • Excellent communication and interpersonal abilities.

    • Ability to work effectively in multicultural environments.

    • Proficiency with pharmacovigilance databases and software.


Preferred Skills:

  • Experience managing pharmacovigilance across 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.


How to Apply:

Interested candidates can apply through the Lilly Careers Portal for more details and application steps.