Pharmacovigilance Specialist
Pharmacovigilance Specialist
Alvotech
Job description
Looking to build a career in pharmacovigilance and drug safety? Explore this Pharmacovigilance Specialist, Safety Data Management role at Alvotech, based in Bangalore.
Company Description
Alvotech is a specialty biopharmaceutical company that focuses on creating and making high quality biosimilar medicines. The company is working to make biologic medicines available to patients all, over the world. Alvotech combines knowledge in science, manufacturing, quality and business activities. The company values teamwork, variety and honesty in everything it does.
Job Summary
This role sits within the Global Safety Data Management team. Reports to the Safety Data Management Director. As a Pharmacovigilance Specialist the Pharmacovigilance Specialist will handle safety and post marketing PV activities. The role covers safety data work, for trials and post marketing programs. The Pharmacovigilance Specialist will also support PV system setup and process development while working independently and ensuring regulatory compliance.
Key Responsibilities
Handle assigned clinical safety and post marketing PV activities such as ICSR and SAE management.
Support regulatory submissions and literature monitoring work.
Carry out digital platform monitoring and reconciliation activities.
Take part in safety system setup and lifecycle management.
Create and maintain global pharmacovigilance processes in line with FDA, EMA, and ICH rules.
Work with other PV teams to support benefit risk management and clinical trial compliance.
Coordinate with Quality, Regulatory, IT, and other internal teams.
Work with external PV service providers and business partners.
Deliver training sessions on pharmacovigilance processes to staff and outside parties.
Support audits and inspections linked to safety data management.
Educational Qualification
Master's degree in pharmaceutical sciences or a related field such as medicine, pharmacy, or life sciences.
Skills Required
At least 3 years of experience in pharmacovigilance or drug safety, with hands on work in safety data management.
Experience with safety systems such as Argus or ARISg. Experience with Veeva Safety Vault is a strong plus.
Proven work experience with global products and clinical trials.
Experience with biologic and combination products is an advantage.
Strong knowledge of PV rules and guidelines such as 21 CFR, ICH, GVP, GCP, and CIOMS.
Strong self organization, time management, and interpersonal skills.
Excellent communication skills and a positive, result driven approach to work.
Ability to work independently in a multicultural team and willingness to travel when needed.
Salary Structure
A Pharmacovigilance Specialist at Alvotech in India typically earns between ₹8 LPA and ₹14 LPA.
Career Development
This role offers exposure to global pharmacovigilance systems and processes within a growing biopharmaceutical company. Alvotech also supports long term career growth through functional work training delivery and a clear path, into senior safety leadership roles. The pharmacovigilance focus remains clear. The biopharmaceutical focus remains clear.
How to Apply
Visit our job portal and search for the Pharmacovigilance Specialist role - Alvotech.
Click on the job posting to read all the details, about the job.
Fill in your details. Upload your updated resume.
Send your application.
Education
Postgraduate Degree (Master's/PhD)
Key Skills
Market insights & trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.