
Safety Operations Manager
2 days ago
Work Schedule
Environmental Conditions
Job Description
PURPOSE OF THE FUNCTION
- Oversees operational delivery and staff within Global Patient Safety (GPS) Operations, in accordance with the GPS vision, strategy and regulatory requirements.
- Interacts with and provides guidance to internal functions and external vendors as required for seamless GPS Operations
ROLES AND RESPONSIBILITIES
- Oversees and coordinates with safety vendor and GPS teams regarding case triage and processing, expedited and aggregate reporting
- Coordinates with and supports deliverables with GPS GSL team in relations to case processing
- Collaborates with other internal teams (including clinical, medical, or regulatory) and external parties (including HCPs, consumers, or contracted resources) regarding safety related deliverables and processes
- Communicates with business partners or distributors regarding deliverables related to PV Agreements (PVA) / Safety Data Exchange Agreements (SDEA).
- Oversees assignment of Safety Specialist tasks, i.e. regarding timely monitoring of GPS communication
- Proactively identifies issues and areas for improvement and escalates appropriately
- Proactively engages in the development of new processes and procedures and leads implementation of those
- Performs all activities in compliance with applicable Controlled Procedures and with global and local regulations as applicable.
- Performs other tasks as assigned by line manager or Head of GPS
SKILLS AND COMPETENCIES
- Advanced knowledge of medical terminology, pharmacovigilance processes and relevant regulations, including global requirements (e.g. EU, US, Japan)
- Proficiency with safety database systems (i.e. Argus) and MedDRA coding
- Advanced computer skills, including proficiency with Microsoft Office including Excel, Power Point, Visio
- Communicates complex issues in an understandable, effective and relevant manner
- Manages and prioritizes a variety of tasks for self and team to meet required deadlines
- Makes operational decisions with limited supervision and has a good understanding of the overall impact and potential risk
- Identifies complex problems, raises issues and proposes solutions constructively
- Proven ability to communicate effectively and collaborate successfully across functions and with vendors
- Advanced communication in written and spoken English required
EDUCATION, EXPERIENCE AND QUALIFICATIONS
- Bachelor's /Master's degree (or local equivalent) in nursing, healthcare or other life-science or relevant field
- Must have JLPT N2 or above level certification
- At least 7 years of relevant experience in global pharmacovigilance/drug safety (EU&US)
- Must have worked on PMDA PV related activities
- Should have hands on experience in managing resource who are working in PV case processing with Japanese Language Proficiency
- Advanced expertise of global (EU/US) pharmacovigilance requirements and practices
- Advanced experience with safety database systems (ARGUS preferred) including workflow management
- Proven experience in interaction with 3rd party vendors
- Proven experience with the identification of quality issues and evaluation of quality metrics
- Willing to work in Japan Timezone
-
Safety And Security Manager
3 weeks ago
India IHG Hotels & Resorts Full timeAs Safety and Security Manager you will fully comprehend the vision of Six Senses to help people reconnect with themselves others and the world around them and our values of local sensitivity and global sensibility crafted experiences emotional hospitality responsibility and caring fun and quirky and pioneering wellness Sustainability Wellness and...
-
Safety Analyst
5 days ago
India EVERSANA Full timeJob DescriptionSafety Analyst (Intern)**Good communication is mustThis position supports of the Pharmacovigilance (PV) Department as both a key team member and contributor in the scheduling and development of aggregate safety reports, generation of project and safety or signal report specific line listings, risk management materials, and safety data...
-
Safety Engineer
2 days ago
India Larsen & Toubro Limited Full time ₹ 4,00,000 - ₹ 8,00,000 per yearJob Description As an EHS Officer/Engineer the person shall assist the workers / staff regarding safety operations and further in the implementation of Environment, Health and Safety measures within the Project He is also responsible for complying with legal and other requirements to ensure an incident free work at Project Key Responsibilities: Facilitate...
-
Supervisor - Safety
16 hours ago
India PI Industries Ltd. Full time**Position Description**: **Business Division**: Fine Chemicals - AgChem**Department**: EHS**Location**: Panoli / Jambusar**Position Title**: Safety Team**Level**: Junior Staff**Reporting To**: Lead Safety**Position Purpose**: - The Safety Team is responsible for implementation of occupational and process safety within the company. The role is also...
-
Health and Safety Professional
17 hours ago
India beBeeWHS Full time ₹ 80,00,000 - ₹ 1,10,00,000Occupational Health and Safety SpecialistThe role of a WHS Officer involves collaborating closely with site operations teams to implement company safety policies and ensure compliance with all relevant local and regional regulations.Key Responsibilities:Drive ongoing improvement initiatives to minimize hazards and improve working conditions, ensuring a safe...
-
Chief - Safety & Health
2 days ago
India Large Chemical Industry, a bluechip Client of Maxima Global Full time ₹ 15,00,000 - ₹ 20,00,000 per yearAbout the Client: Our client is major Player in Chemicals business in Asia, enjoy leadership status in most of the product categories . They have state-of-the-art manufacturing plants located across the region and to implement world class safety and hygene standards they are currently looking for a seasoned professional to lead the HSE & sustainability...
-
Safety, Health
7 hours ago
India Olam International Full time US$ 90,000 - US$ 1,20,000 per yearOlam Agri ~ A differentiated, and market leading global agri-business focused on high-growth end consumption markets. Our food, feed, fibre, agri-industrials & ag-services capabilities span 30+ countries, and we participate in global food and agri-trade flows, working with farmers and customers to connect local origins and global destinations. With a...
-
Drug Safety Associate
16 hours ago
India Novotech Asia Full timeBrief Position Description: Responsible for complete and accurate case processing of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations. **Minimum Qualifications & Experience**: - A minimum of 1- 3years of industry...
-
Safety Manager Role
6 days ago
India beBeeEnvironmentalHealthSupervisor Full time ₹ 8,00,000 - ₹ 15,00,000Job OpportunityThe Environmental Health and Safety (EHS) Supervisor is responsible for maintaining a safe work environment. This involves conducting daily safety inspections, investigating incidents, and implementing corrective actions.
-
Fleet Operations Manager
5 days ago
India beBeeMaintenance Full time US$ 1,01,685 - US$ 1,38,422Fleet Maintenance Process ManagerWe are seeking a highly skilled professional to manage and maintain our fleet's maintenance processes, ensuring high service quality and uptime.Ensure efficient management of maintenance operations in Latin America.Establish and maintain maintenance operations aligned with corporate standards.Collaborate with leadership to...