Raghunath Dhule
Senior Manager Pharmacovigilance /QPPV/Pharmacovigilance Officer In-charge (PvOI)
- Role
- Senior Manager Pharmacovigilance Qppv Pharmacovigilance Officer Incharge (Pvoi) at Eli Lilly and Company
- Location
- Gurugram, HR, IN
- LinkedIn followers
- 500 followers
About Raghunath Dhule
An ACRP certified Clinical Research professional with experience in Pharmacovigilance…
Experience
Senior Manager Pharmacovigilance Qppv Pharmacovigilance Officer Incharge (Pvoi)
Sep 2022 — Present
Safety Responsible person for Eli Lilly - India, Sri Lanka, Nepal, Bangladesh along with SAMETA Region (Middle East, Turkey)• Ownership of pharmacovigilance in India, Sri Lanka, Pakistan, Bangladesh and Nepal in order to safe guard public health and ensure compliance with applicable local and global pharmacovigilance regulatory requirements and also company policies.• Develops and implements local controlled procedural documents (SOPs, PV Agreement and PSMF)for applicable local PV processes in collaboration with appropriate functional heads. • Monitors and report domestic Adverse Drug Reaction (ADR)/Adverse Event (AE), including special situations, for all locally marketed and investigational products of the client in assigned countries.• To maintain functional oversight of distributors, partners and third party vendors with the responsibility for PV activities.• Nominated person for PV where required by national regulation.• To actively monitor and provide inputs for the preparation and implementation of appropriate actions in response to emerging safety concerns (urgent safety restrictions, communication to patients and healthcare professionals).• Responsible for preparing Local PV training materials (in collaboration with Global training group) and organise/ Provide PV training for relevant company employees/ business partners, contractors and third party vendors.• Establish and maintaining Quality Management System for PV activities in India subcontinent in accordance with local and global processes and in collaboration with SOP and policies.• To liaise directly or indirectly with responsible country’s regulatory bodies on regular basis and as and when required.• Review of contracts and provide inputs for various vendors in accordance with PV policies.• Schedule, Review and regulatory submissions of PSURs and signals, RMPs. Work closely with SARM teams to define and update on requirements of aggregate reports
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