Pharmacovigilance (PV) Specialist - ROW Market

We are seeking a dedicated and detail-oriented PV Specialist to join our team. The associate will work under the guidance of respective Head of Pharmacovigilance of the assigned region and shall be responsible for managing various pharmacovigilance tasks. The ideal candidate will have excellent communication and organizational skills, as well as a strong understanding of regulatory requirements in ROW countries.

Responsibilities:

• Assist in updating both local and core PSMFs
• Collaborate with partners to create and update SDEAs with the latest consumer healthcare information under the supervision of the Head of Pharmacovigilance of ROW region.
• Ensure compliance with SDEA requirements, such as reconciliation of PV activities in ROW region.
• Keep activity tracking spreadsheets up-to-date to ensure all tasks are consistently monitored and recorded.
• Manage the Eudravigilance database and perform signal detection activities as required.
• Manage RMP queries and CMDh risk notifications.
• Update RMPs post-authorization and track related variations with RA.
• Ensure compliance for aggregate reports, including PSUSAs, for regulatory intelligence and tracking tasks to be addressed in the next PSUR, as well as establishing a close monitoring list.
• Manage deviations and CAPAs: Identify and report any deviations in procedures and participate in CAPA development, assuming responsibility for CAPA completion when assigned.
• Provide support during audit and inspection preparation, actively participate during audits, address any observations, and assist in CAPA closure
• Able to manage any assigned task of Pharmacovigilance on ad-hoc basis.

Relationship Management

• Working with other regional teams and central cross functional teams across the Globe.
• Interactions with vendor's/service providers for PV activities.

Process Improvement / Standardization

• Participate in process improvement initiatives under supervision of Head of Pharmacovigilance of respective region.

Qualifications

Desired Skills & Competencies

• Bachelor's degree in pharmacy, Master's degree is preferred.
• Minimum 8 years of experience in pharmacovigilance out of which at least 3 years in core pharmaceutical company.
• Strong understanding of regulatory requirements and guidelines of respective countries
• Excellent communication and organizational skills
• Proficiency in Microsoft Office, including Excel, PowerPoint
• Ability to work independently and as part of a team.
• Detail-oriented and able to manage multiple tasks simultaneously.

Skills Required
Compliance with regulatory guidelines, Pharmacovigilance tasks management, RMP management, SDEA creation, Signal detection