707 Pharmacovigilance jobs in India

Company Description

Cipla Pharmaceutical Limited., Kurkumbh, Pune, is a biotechnology company based in Pune, Maharashtra, India. The company is located in Flat No 10, Sanskruti Apt, Near Gokul Hotel, Dound. Cipla is dedicated to developing and manufacturing high-quality pharmaceuticals that contribute to a better quality of life for patients. Cipla is recognized for its commitment to innovation and excellence in the pharmaceutical industry.

Role Description

This is a full-time on-site role for a Pharmacovigilance Manager located in Narkhed. The Pharmacovigilance Manager will be responsible for monitoring the safety of pharmaceutical products, managing adverse event reporting, and ensuring compliance with regulatory requirements. Daily tasks include evaluating reports, preparing safety data, liaising with regulatory bodies, and providing risk management plans. The role also involves coordinating with cross-functional teams to ensure the safety and efficacy of products.

Qualifications

• Knowledge of Regulatory Requirements and Regulatory Affairs
• Background in Pharmacy, Pharmaceuticals, and Medicine
• Excellent analytical and problem-solving skills
• Strong written and verbal communication skills
• Ability to work independently and in a team environment
• Experience in Pharmacovigilance or related fields is a plus
• Bachelor's or advanced degree in Pharmacy, Medicine, or a related field

1. In depth knowledge of Indian / Global (EU, US and TGA) pharmacovigilance guidelines / regulations
2. Strong knowledge and understanding of medical terminology and clinical development processes

Required Candidate profile

Function/department Pharmacovigilance

only accepted who has worked in pharma company in this function

Company Description

At Novaspire Biosciences, we pride ourselves on being a trusted partner to the pharmaceutical industry, delivering comprehensive, high-quality clinical research services. We specialize in supporting pharmaceutical, biotechnology, medical device, and nutraceutical companies at every stage of the drug/product development lifecycle, from clinical studies Phase I to post-market surveillance. Our core services include pharmacovigilance, clinical trials, medical writing, bioequivalence study support, GxP consulting services & training, and imaging studies. With over 75 years of combined experience, our team provides solutions and streamlined processes to ensure efficient and effective research outcomes.

Role Description

• Organize, manage and maintain a highly compliant Pharmacovigilance (PV) system

• Maintain awareness and ensure adherence to established and updated local and global processes and guidelines as well as national and international regulations and guidelines for pharmacovigilance.

• Ensure PV business continuity and after hours availability.

• Lead and coordinate internal and external PV audits and inspections.

• Monitor PV system performance and compliance of partners and distributors.

• Maintain expertise in country as well as worldwide regulations and guidelines and promote increased awareness of the legislative and regulatory environment in the country.

• Accountable for all strategic PV activities

• Active contribution to the activities relevant to the pharmacovigilance system to ensure monitoring of the safety profile

• Act as the responsible contact person in the region, internally and externally, for safety-related aspects and PV.

• Ensure internal regulatory/PV processes and procedures are well documented and support compliant regulatory/PV activities.

• Perform other duties as assigned.

Skills Required:

• In depth knowledge of national/regional regulatory legislation and guidelines.

• Knowledge of the pharmacovigilance regulations of all the countries.

• Demonstrated ability to provide quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team locally, within PV and externally.

• Skilled at people management including overseeing and controlling outsourced vendor activities in a compliance/regulated field.

• Capable of troubleshooting and managing multiple projects simultaneously.

• Strong knowledge and understanding of medical terminology and clinical development processes

• Rational approach to issues and their business implications, good problem solving and decision making skills.

• Highly analytical with the ability to give attention to detail.

• Excellent organizational skills and capable of working efficiently.

• Possess an excellent interpersonal, verbal, and written communication skills.

Minimum Requirements:

• Minimum five years of working experience within the pharmaceutical industry and minimum five years within pharmacovigilance.

• Degree / Advanced degree in medicine or in life sciences or equivalent experience

• Excellent communication skills including proficiency in verbal and written English

• Experience in other affiliate medical functions (e.g., Medical Affairs, Clinical Operations, Medical Information) or global clinical product development is considered advantageous.

• Proficiency in Microsoft Word and Excel.

Education : EQUIVALENTEXPERIENCE

At Elanco (NYSE: ELAN) – it all starts with animals

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals' lives better makes life better – join our team today

To be added

Elanco is an EEO/Affirmative Action Employer and 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

Role & responsibilities

• Manage pharmacovigilance activities including adverse event reporting and vigilance documentation.
• Ensure compliance with USFDA, EU MDR, ISO 13485 and global regulatory requirements
• Prepare pharmacovigilance data, safety reports, and regulatory submissions/dossiers
• Conduct post market surveillance, risk assessments and trend analysis
• Handle product recalls, field corrective actions, and regulator communications
• Support product registrations, renewal and audits across global markets
• Liase with cross functional teams (R&D, Quality, Manufacturing) for compliance.

Preferred candidate profile

Strong knowledge of pharmacovigilance reporting systems, dossier filing and regulatory submissions.

Strong Analytical, documentation and communication skills.

Regulatory compliance mindset

• Perform case processing of Adverse Event (AE) reports from various sources (spontaneous, literature, clinical trials).
• Enter and update safety data into safety databases with accuracy and timeliness.
• Assist in narrative writing and medical coding of adverse events using MedDRA.
• Conduct literature screening for safety information as per regulatory requirements.
• Ensure compliance with global regulatory requirements and internal standard operating procedures (SOPs).
• Support in preparing periodic safety update reports (PSURs) and risk management documents.
• Collaborate with cross-functional teams such as medical writing, regulatory affairs, and clinical research.
• Bachelor's or Master's degree in Pharmacy, Life Sciences, Medicine, Nursing, Biotechnology, or related discipline.

Job Types: Full-time, Permanent, Fresher

Pay: ₹360, ₹578,383.71 per year

Benefits:

• Health insurance
• Paid sick time

Work Location: In person

Clin Infotech is Offering Internship Opportunity For Freshers to gain Work Experience on Live Projects and Clinical Software's in Clinical Research and Pharmacovigilance

Internship Is followed with Certification Course in Clinical Research.

Required Candidate profile

Should be pharmacy & Life Science Graduates

Should have done Certification Course in Clinical Research and Pharmacovigilance

Diploma in Clinical Research will be Preferable

Good Communication Skills

Perks and benefits

Please apply through only.

Job Overview

The Executive Pharmacovigilance will be responsible end-to-end case management, including case receipt, case follow-up,database entry, review and submission to applicable regulatory authorities within stipulated timelines.

Required Candidate profile

Any Pharmacy or Pharm D with Certification in Pharmacovigilance can Apply

Should have Good Communication Skills

Should have strong knowledge on Argus Safety Database and Case Processing and MedDRa

Activity Manager: Program Lead-Pharmacovigilance

Duration: 6 months (Extendable subject to project extension, programmatic needs and budget approval)

Please Note: Prior 1-2 years of experience in Adverse Drug Reaction reporting, MedDRA coding and/or signal detection processes are essential requirement for this role. Only relevant candidates need to apply.

Project Overview

• The Universal Immunization Programme (UIP) of the Government of India (GoI) aims to achieve full immunization of all target-age children and mothers in India, through state and district-specific delivery of vaccines.
• India declared 2012 as the year of strengthening routine immunization (RI).
• To augment its ongoing efforts around immunization, the Ministry of Health and Family Welfare (MoHFW), GoI has now entrusted JSIPL with the management of the Immunization Technical Support Unit (ITSU) in collaboration with other partners.
• This effort emphasises addressing national programs and priorities in delivering real change and impact by working closely with the health system, government and key stakeholders including civil society organisations.
• The ITSU, provides techno-managerial support for scaling up the UIP, enabling system strengthening for providing quality services and supporting implementation of MoHFW Multi-Year Strategic Plan for Immunization.
• The ITSU will focus on providing technical input to the GoI, MoHFW and coordination with immunization partners to help India accelerate progress in achieving 90% full immunization coverage (FIC).

Job Summary

• The Consultant will support Programme Lead - Pharmacovigilance in functionality of the Signal detection and management processes as part of the AEFI Secretariat.
• The incumbent will work on identifying and conducting assessments of priority identified signals; develop dossiers for each signal with data and information from different sources (large pharmacovigilance databases, systematic reviews, case studies in journals, clinical trial reports, etc.), assessment reports, vaccine specific safety database, etc. till specific end points for signal detection.
• Prepare summaries and presentations of each processed signal for sharing with experts during signal review panel meetings.

Responsibilities

• Support Programme Lead-Pharmacovigilance for the smooth and efficient functioning of the Signal Management Activities
• Conduct literature search on vaccine adverse events and vaccines
• MedDRA Coding of the reported AEFIs
• Assess each signal using the available information from each source and record in a crisp report with recommendations as per international standards
• Prepare power point presentations for each signal for sharing with Signal Review Panel
• Support the organization and conduction of signal review panel meetings and minute them
• Develop and maintain dossiers for each signal under assessment which includes properly indexed references of sources of information and data
• Ensure recommendations of the signal panel review meetings are shared with all stakeholders
• Regularly review national and international scientific evidence and support in knowledge management
• Assist in any other research and programmatic work for day-to-day functioning, as required

Qualifications and Skills

JSIPL seeks a results-oriented individual with the ability to work across teams in producing high quality deliverables, managing multiple concurrent tasks, and meet tight deadlines with attention to detail. The successful candidate is required to have:

• A minimum qualification of Pharma D or M Pharma (Pharmacology or Pharmacy Practice or Clinical Pharmacy), or B.D.S. is required
• One-Two years experience in Adverse Drug Reaction reporting, MedDRA coding and/or signal detection processes are essential requirement for this role.
• Demonstrated ability to conduct extensive literature searches and review, collate information from different sources in a coherent manner and prepare concise reports
• Ability to work on large pharmacovigilance databases such as VigiBase, VigiLyze, ARGUS etc.
• Excellent verbal and written communication skills interpersonal relations, work in a multi-cultural team environment, and work harmoniously with multiple partners.
• Good working knowledge of computer applications, especially MS Office.
• Strong and proven documentation and organizational skills.