Regional Pharmacovigilance Senior Officer | Bayer | Thane

Job Description

Regional Pharmacovigilance Senior Officer

Purpose:

The Regional Pharmacovigilance Officer position belongs to the PV Regional Center. The main purpose of the position is to ensure that Bayer Pharmacovigilance (PV) standards are met by performing and bringing expertise in case management, PV process management, as well as PV, benefit-risk management activities. The Regional PV Officer contributes to assuring patients’ safety by complying with all PV Quality System Documents (QSDs) and local and international regulatory requirements. The Regional PV Officer (Senior) value added to the success of the company by:

• Ensuring best practice, standardization, and high compliance rates in Pharmacovigilance to assure the safety of patients and of company products
• Building and fostering relationships through effective communication and collaboration between all internal and external stakeholders, while at the same time ensuring that the highest PV standards are maintained
• Ensuring a high company compliance rate with respect to current legislation fulfilling the regulatory requirements and following the company QSDs for all activities covered by the PV Regional Center

ROLE AND RESPONSIBILITIES:

• PV Case Management: Execute all matters regarding PV cases/Product Technical Complaint (PTC) handling relating (but not limited) to:
  • PV case receipt and transfer to Argus where applicable. Identification of PV cases where missing or unclear information is provided and performs clarification as needed
  • Coordination of translation of PV case source documents
  • PV case data entry in Argus Safety Database, where applicable, as well as perform quality control of PV cases
  • Liaise with the Country Quality Function in relation to PV cases associated with PTCs and aligns on actions
  • PV case reconciliation with internal and external partners
  • Report PV cases to Health Authorities, Investigators, and Ethics Committees where applicable
• PV Process Management: Executes a high-quality oversight of the PV process, and improves processes and compliance management by:
  • QSD management for local PV teams
  • Assist local PV CAPA management
  • Support preparation, roll-out, and conduct of PV training given to local organizations
  • Perform local Pharmacovigilance Contract Management (PV agreement drafting and finalization, annual PV agreement review etc.) for countries supported by PV Regional Center
  • Inspection and audit preparation in collaboration with local PV teams and global inspection management
  • Generate local Pharmacovigilance System Master Files
  • Functional lead to PV Regional Center team members
  • Provide mentorship and guidance to Regional PV Officers on Process Management tasks
  • Deputize Process Management Team Lead on Process Management Task Oversight during the absence

• PV Benefit Risk Management: Manages the safety and benefit-risk profile of Bayers products by:
  • Generating Aggregate Safety Reports, e.g. Periodic Benefit Risk Evaluation (PBRER) / Periodic Safety Update Reports (PSURs), Addendum Reports, Bridging Reports, etc.
  • Generating local Risk Management Plans
  • Adapting global Risk Management Plans to local requirements
  • Setting up procedures for local signal detection as well as conducting local signal detection and management as applicable

Desired Candidate Profile:

• A scientific degree related to the area, with 3-5 years of experience in the pharmaceutical industry, preferably in Pharmacovigilance
• Experience in leading functional teams in an international and multi-country setting
• Excellent English language (written and verbal communication)
• Team worker, able to work under tight timelines
• Good communication skills
• Excellent organizational skills with the ability to find solutions (technical and non-technical) in a complex environment
• Ability to follow and adhere to procedures and to make process improvement proposals

Qualification: B.Pharma, B.Sc, BDS, MS, M.Sc, MDS, M.Pharma