Local Safety Specialist

Description:

• PV-Safety training support external and internal, Aggregate reports, PV contract management, Safety regulations, Local Communications, Local Safety compliance
• Provide Risk Management Plan status updates:
• Involvement in implementation of Risk Management Plans and Urgent Safety Restrictions, if required.
• Participate in meetings with relevant stakeholders for discussion and evaluation of topics related to benefit risk and product safety as required.
• Involvement in local safety obligation as well as global company requirements
• The role is not involved in the case processing procedure.
• Collaborate with the QPPV as required.
• Support activities related to safety reporting requirements as required by Marketing Authorization Holders (MAH) as applicable.
  
  

Qualifications:  Sound knowledge of general medicine or pharmacy and clinical practice, or relevant

scientific/medical field.

 Proven ability to organize workflow activities and manage multiple critical issues.

 Awareness of and familiarity with industry principles of product vigilance, drug development and

pharmacology.

 Expert knowledge of Global, Regional and Local Procedural Documents as applicable.

 Computer literate with knowledge of relevant IT safety systems.

 Excellent verbal and written communication skills with proven ability to negotiate and communicate

with internal and external customers.

 Ability to establish and maintain open relationships within the organization and with authorities.

 Demonstrable knowledge of all local requirements and of global aspects of product safety.

 Fluency in the national language and the English language is required.

 Excellent computer proficiency

 Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.

 Must be able to work independently with minimum supervision to meet tight deadlines