General Manager - Pharmacovigilance

Job Profile:

- Overall in-charge of Pharmacovigilance activity

- Acts as a management level liaison between the sponsors & the working group in PV

- Would ultimately handle a team of 200 and will be in close touch with the clients

- Supervises & supports Budgeting & Planning, Organization & Co-ordination of all internal & external activities supporting PV

- Be responsible for quality delivery through a rigorous metrics based approach and balancing with high productivity and work load balancing

- Be responsible for recruitment, selection, training of team members to the level of project manager & group team leaders (n-2) & managing attrition.

- Manage a high level of employee satisfaction

- Acts as guide coach counselor for the team.

Desired candidate profile:

- Minimum 8+ year experience in leading projects in PV and having an overall experience of 13-15 years. Experience in CRO/FSP setup is desirable

- Good knowledge of pharmacovigilance practices, particularly in relation to signal detection and evaluation

- Good knowledge of US and EU pharmacovigilance regulatory requirements

- Excellent written and verbal communication skills and ability to present and critically discuss clinical data in both internal and external discussions

- Experience in dedicated software like AERS, AWARE, ARIS G, ARGUS & exposure to other CDMS software

- Experience and understanding of ICH GCP principles, clinical drug development process, organizational, communication and data management skills

Other Skills and experience:

- Capability to lead by motivation and example

- Ability to prioritize schedule and organize.

- Excellent interpersonal and communication skills

- General knowledge of Clinical Trials and Pharmaceutical Industry