Vijay Linga

Vijay Linga holds M.Sc., pharmaceutical medicine, accomplished drug Safety associate in PV and regulatory. I am a dedicated and highly motivated professional with experience in pharmaceuticals, medical devices, case management, regulatory submissions, community pharmacy, hospital pharmacy. I am confident and flexible to adopt any circumstances, and flexible leadership style and team-building skills. Preparation and registration of medical devices, including consumable, electronic devices. Sound understanding of regulatory standards and legislation for UK, EU and Asian pharmaceuticals. Ability to meet timeliness strictly in patient safety, surveillance, regulatory submissions. I am flexible to relocate or hybrid work or remote.

• Ability to work with business partners across geographies and time zones.
• Good document control and data protection in regulatory
• Aggregate reporting in case processing for regulatory safety assessment
• Team-building skills
• Proficient computer knowledge in Microsoft Office Suite (Outlook, Word, Excel).
• Working knowledge, understanding of the legal, regulatory, and pharmacovigilance environment within the pharmaceutical industry.
• Excellent internal and external customer service skills, teamwork, and interpersonal skills.
• Strong verbal, written, and interpersonal communication skills with clients and internal staff.
• Excellent attention to detail.
• Organization, prioritization, project management, delegation, and attention to details skills.
• Able to work independently and collaboratively in a multidisciplinary team.
• Able to occasionally work extended and/or flexible schedules to meet client requirements.
• SOP, SMP draft and review experience as per the client requirements.
• Experience of using EDMS to organize, edit and QC the data. 

Case processing, QC, Training and mentoring, e ctd and CTD preparation, team management, medical device regulations.