Executive - Pharmacovigilance

Jubilant Pharma

2-3 years

Not Disclosed

Greater Noida

10 Jan. 27, 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: Executive - Pharmacovigilance
Organization: Jubilant Pharma Limited
Location: Greater Noida
Department: Pharmacovigilance

About Jubilant Pharma Limited:

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services across various geographies. The company is organized into two primary segments:

Specialty Pharmaceuticals: Includes Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs.
Generics & APIs: Focused on Solid Dosage Formulations and Active Pharmaceutical Ingredients (APIs).

Jubilant Generics (JGL), a wholly-owned subsidiary of Jubilant Pharma, operates R&D units in Noida and Mysore, along with manufacturing facilities in Mysore (engaged in API production) and Roorkee (manufacturing Solid Dosage Forms). These state-of-the-art facilities cater to the global market and are approved by leading regulatory agencies, including the USFDA, TGA, WHO, PMDA, UK MHRA, and ANVISA.

Jubilant Pharma’s revenue continues to grow, reaching INR 53,240 million in FY 2018-19.

For more information, please visit Jubilant Pharma.

Job Description:

As an Executive - Pharmacovigilance, you will be responsible for managing and supporting the pharmacovigilance processes to ensure the safety and efficacy of the company’s products. You will work closely with cross-functional teams to ensure compliance with regulatory requirements and internal safety standards. The position requires thorough knowledge of pharmacovigilance processes, including data collection, reporting, and risk management of medicinal products.

Key Responsibilities:

Monitor, assess, and report adverse drug reactions (ADRs) and other safety-related issues.
Manage and track safety data related to product development and marketed products.
Ensure compliance with local and international pharmacovigilance regulations, including regulatory reporting timelines.
Perform risk management and benefit-risk analysis for drug safety assessment.
Maintain and update pharmacovigilance databases.
Prepare and submit periodic safety update reports (PSURs) and other regulatory submissions.
Collaborate with clinical and regulatory teams for safety-related concerns.
Liaise with external stakeholders such as healthcare professionals, regulatory authorities, and service providers on pharmacovigilance matters.
Monitor trends in safety data and perform signal detection.
Provide training on pharmacovigilance processes and safety reporting.

Qualifications and Skills:

Educational Qualifications:
- Bachelor’s degree in Pharmacy, Life Sciences, or a related field (PhD or Masters is a plus).
Experience:
- Minimum of 2-4 years of experience in pharmacovigilance or drug safety within the pharmaceutical or healthcare industry.
Skills and Knowledge:
- Knowledge of pharmacovigilance regulations and global safety reporting requirements.
- Familiarity with ICH E2E guidelines, CIOMS forms, and safety databases.
- Strong communication skills, both written and verbal.
- Attention to detail and the ability to work in a fast-paced environment.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Other Qualities:
- Analytical thinking with problem-solving capabilities.
- Ability to work independently as well as within a team.
- Strong organizational and time management skills.

Compensation and Benefits:

Competitive salary and performance-based incentives.
Comprehensive benefits package, including health insurance, retirement plans, and more.
Opportunities for professional development and growth within the company.

Jubilant Pharma Limited is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, color, gender identity or expression, genetic information, marital status, medical condition, national origin, political affiliation, race, ethnicity, religion, or any other characteristic protected by applicable local laws, regulations, and ordinances.

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Executive - Pharmacovigilance

Job Description

About Jubilant Pharma Limited:

Job Description:

Key Responsibilities:

Qualifications and Skills:

Compensation and Benefits:

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