PHARMACOVIGILANCE - MANAGER / Sr. MANAGER

Hetero Labs Limited

Hyderabad

0-1 Years

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Posted a day ago
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Job Description

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

More Info

Job Type:

Permanent Job

Industry:

Manufacturing, Pharmaceutical

Role:

Clinical Research Associate /Manager

Function:

Pharmaceutical/Biotechnology

Employment Type:

Full time

Open to candidates from:

Indian

About Company

Hetero Labs Limited

We are one of the world’s leading producers of key Active Pharmaceutical Ingredients (APIs) and generic formulations with a presence in 140+ countries and backed by 30 years of experience in the pharma sector. We endeavour to serve patients by moulding science and technology into therapies to improve health outcomes and people’s lives.

Job ID: 122723095

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