Gorakshanath Kakde
Assistant Manager| Team Lead|Project coordinator|Pharmacovigilance| Argus| Arisg| CT| Literature review|MedDRA|WHODD| ICD10| ICH GCP|GMP| Regulatory Submission|cIRB|eTMF|Veeva QMS|SAE Recon|
- Role
- Assistant Manager at Tata Consultancy Services
- Location
- Pune Division, MH, IN
- LinkedIn followers
- 500 followers
About Gorakshanath Kakde
PV & Patient Safety| Training Lead| Ast Manager | Team Lead, 10+ Years in Clinical…
Experience
Assistant Manager
Jan 2023 — Present · Pune, IN
Responsibilities include and are not limited to overall accountability of day-to-day case processing activities including Service Level Agreement monitoring (productivity, quality, and compliance).• Ensuring adequate resource availability in team, accountable for proactive workload management within team and across the function to ensure that internal and regulatory timelines are met.• Providing technical expertise to team and mentor/train team members on ongoing basis in day-to-day activities of Pharmacovigilance projects• Proactively identifying trends in compliance and proposing solutions to case processing and resourcing issues.• Solid experience and understanding of ICH, GCP and GVP principles, clinical drug development process, organizational, communication and Drug Safety (Pharmacovigilance) management skills.• Identifying and implementing continuous improvement activities.• Maintaining, monitoring, and tracking records relating to training, productivity, compliance, and quality of Drug Safety teams.• Ensuring individuals within the Drug Safety team are audit and inspection ready.• Motivating and encouraging individuals and/or team when required and appreciation of good work.
Education
Yeshwantrao Chavan College Sillod
Hsc
2009 — 2010
Dr. Vedprakash Patil College of Pharmacy, Georai Tanda.
Bachelor’s Degree
2010 — 2014
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.