Bayer Foundations vision is to catalyze advances in Science and Social Innovation for a world with Health for all, Hunger for none. There is no meaningful progress without science and social innovation. Fundamental research and cutting-edge advances in science are the basis for progress. Social innovators bring concrete and long-lasting change to people and communities.
Post : Sr. Regional Pharmacovigilance Officer
Job Description
The Regional PV Officer (Senior) position belongs to the PV Regional Center. The Regional PV Officer (Senior) contributes to assure patients’ safety by complying with all PV Quality System Documents (QSDs) and local and international regulatory requirements. The main purpose of the position is to ensure that Bayer Pharmacovigilance (PV) standards are met by performing and bringing expertise in case management and PV process management activities.
Tasks and Responsibilities
• Supports the PV Regional Center Manager on keeping oversight of the activities and tasks handled by external service suppliers.
• Supports the Local PV teams serving as functional support for source document handling / source document upload in SDRA during absences. Additional country specific tasks can be also covered depending on local situation.
• Tasks may include one or a combination of the two areas listed below:
PV Case Management:
Executes 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.
• Case follow up and action item handling activities.
• Coordination of translation of PV case source documents.
• Liaises with the Country Quality Function in relation to PV cases associated with PTCs and aligns on actions, if required.
• PV case reconciliation with internal and external partners.
• Reporting of PV cases to Health Authorities, Investigators and Ethics Committees where applicable.
PV Process Management:
Executes a high-quality oversight of PV process, improves processes and compliance management by:
• QSD management.
• Assisting local PV CAPA management.
• Supporting preparation, roll-out and conduct or assignment of PV trainings to local organizations and external vendors/partners.
• Supporting local Pharmacovigilance Contract Management.
• Inspection and audit preparation in collaboration with local PV teams and global inspection management.
• Generating local Pharmacovigilance System Master Files.
• Supports the mentoring of junior team members in the day-to-day operational activities, as applicable.
Candidate Profile
• Scientific degree related to the area, with 3-5 years’ experience in the Pharmaceutical industry, preferably in Pharmacovigilance
• Experience in leading functional teams in an international and multi-country setting
• Mentoring team members within the PVRC
• 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
• Independent problem solving skills
• Knowledge of major concepts in data management and systems
Additional Information
Experience : 3-5 years
Qualification : Scientific degree related to the area
Location : Maharashtra : Thane
Industry Type : Pharma/ Healthcare/ Clinical research
Reference Code : 819525
End Date : 10th July 2024
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