HE

PHARMACOVIGILANCE - MANAGER / Sr. MANAGER

Hyderabad ₹4-10 LPA Posted 28 Jul 2025

FULL TIME

sop development

Regulatory Compliance

Responsible for handling end to end Case management (ICSRs) activities and to ensure the compliance.
Manage assigned team and ensure that all tasks are performed according to guidelines and standard operating procedures.
Consulting and guiding the pharmacovigilance team for completion of aggregate reports (PSURs, PADERs, RMPs and applicable regulatory submission PV documents) as required for regulatory submission
To develop and review pharmacovigilance SOPs.
Coordination with MICC for ICSR activities and regulatory compliance.
Coordinating the safety data exchange agreements between Hetero and business partners.
Responsible for providing guidance and training to team as and when required.
Responsible for identifying, implementation and continuous improvement activities.
Responsible to handle audits and inspections