Instagram
youtube
Facebook

Manager/Sr. Manager-Pharmacovigilance

5-7 years
Not Disclosed
10 April 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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 (Oversees India, Bangladesh, Nepal, Sri Lanka)


Company:

Lilly


Job Description:

The Manager/Senior Manager - Pharmacovigilance will oversee pharmacovigilance activities across multiple regions (India, Bangladesh, Nepal, and Sri Lanka). This includes ensuring compliance with regulatory requirements, managing safety data, leading a team, and maintaining the highest standards of drug safety. The candidate will develop processes, assess adverse drug reactions (ADRs), and manage risk assessments.


Key Responsibilities:

  • Pharmacovigilance Management:

    • Oversee compliance with local and international pharmacovigilance regulations.

    • Collect, assess, and report adverse drug reactions (ADRs) and other safety data.

    • Develop and implement pharmacovigilance processes and procedures.

  • Leadership:

    • Lead and mentor a team of pharmacovigilance professionals.

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

  • Reporting and Risk Management:

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

    • Conduct risk assessments and develop risk management plans.

  • Regulatory Liaison:

    • Liaise with regulatory authorities and external stakeholders as necessary.

    • Stay updated on the latest pharmacovigilance regulations and guidelines.


Required Qualifications:

  • Education:

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

  • Experience:

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

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

  • Skills:

    • Strong leadership and team management skills.

    • Excellent communication and interpersonal skills.

    • Proficiency in pharmacovigilance databases and software.

    • Ability to work in a multicultural environment.


Preferred Skills:

  • Experience handling pharmacovigilance activities for multiple countries.

  • Certification in pharmacovigilance or related fields.

  • Strong analytical and problem-solving skills.

  • Ability to manage multiple projects and deadlines.


Benefits:

  • Competitive salary and benefits package.

  • Opportunities for professional growth and development.

  • Collaborative and inclusive work environment.