Abbott Hiring PV Specialist | Pharmacovigilance Job | Pharma Job Opportunity
Looking for a Pharmacovigilance Job or a Pharma Job in India? This PV Specialist role at Abbott offers an excellent opportunity for candidates interested in drug safety, regulatory compliance, and medical affairs. If you are a life sciences or pharmacy graduate, this Pharmacovigilance Job in Mumbai is a great Pharma Job to start or grow your career.
- Job Title: PV Specialist
- Location: India – Mumbai
About the Company
Abbott Laboratories is a global healthcare company focused on improving lives through the development of medicines, medical devices, diagnostics, and nutritional products. Abbott operates in more than 160 countries and is known for its strong commitment to quality, innovation, and patient safety.
Job Description
- Supports ASR in all pharmacovigilance (PV) activities for Abbott EPD products (investigational & registered)
- Ensures compliance with internal Abbott policies and local regulatory requirements
- Covers PV activities for India and neighboring countries (Nepal, Bhutan, Maldives, Sri Lanka)
- Acts as an interface between Abbott EPD and local health authorities
- Represents pharmacovigilance within the affiliate organization
- Serves as back-up for ASR for all applicable PV activities
Key Responsibilities
- Maintain PV quality system (procedures, templates, training matrix)
- Ensure PV business continuity and report any compliance risks
- Handle receipt, recording, and reconciliation of safety data
- Conduct safety surveillance and prepare periodic reports & risk plans
- Manage regulatory submission of safety information
- Provide basic PV training to local staff
- Maintain PV records, archiving, and product list
- Ensure safety data collection in studies and data programs
- Support PV agreements and due diligence activities
- Monitor PV compliance metrics and manage non-compliances
- Coordinate PV audits and inspections
- Ensure compliance for drugs, medical devices, and food supplements
- Review prescribing information and PV aspects of programs (MRS/PSP/digital)
- Ensure regulatory compliance across India and neighboring regions
- Maintain Pharmacovigilance System Sub File (PSSF)
Scope/Accountabilities
- Responsible for the implementation and maintenance of a compliant local PV system
- Ensures adherence to local regulations and Abbott internal requirements across multiple countries
- Acts as PV interface with local health authorities
- Serves as PV point of contact for non-PV functions and global PV teams
- Collaborates with stakeholders for the timely exchange of PV-related information
- Supports regional/global PV projects as assigned
Qualification
- Ideally, graduate with a Pharmacy degree or equivalent qualification
Experience Required
- PV experience in a pharmaceutical company is preferred
- Understanding of local PV regulation
- Ability to give attention to the detail
- Computer literacy (Windows, MS Office)
- Good English language skills
- Good communication skills with internal and external stakeholders.
