141 Safety Director jobs in India

Job Overview
Provide medical expertise on pharmacovigilance services to divisions as requested. The Associate Medical Safety Director participates in all aspects of Medical Safety's involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors.
Essential Functions
- Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary
- Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements
- Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
- Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product's safety profile
- Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
- Represent safety and clinical data review findings during client meetings
- Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports
- Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies
- Provide medical oversight for label development, review and change
- Provide medical support and attendance at Data Safety Monitoring Board Meetings
- Attends and contributes medical safety evaluation on Safety Monitoring Committees
- Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document
- Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments
- Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract
- Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture.
- Act as Global Safety Physician or Assistant or Back-up on projects as assigned
- Attend project meetings, medical safety team meetings, and client meetings as requested
- Ensure coverage for all medical safety deliverables within regulatory or contracted timelines
- Provide medical escalation support for medical information projects
- Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects
- 24 hour medical support as required on assigned projects
- Maintain awareness of medical-safety-regulatory industry developments
Qualifications
- Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req
- Three (3) years of clinical practice experience (e.g graduate medical training) with two (2) additional years in the pharmaceutical or associated industry in any role. Or equivalent combination of education, training and experience Req
- Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice
- Knowledge of clinical trials and pharmaceutical research process
- Ability to establish and meet priorities, deadlines, and objectives.
- Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled

Job OverviewProvide strategic leadership at customer (or strategic) account level for large post-marketing, clinical trial or combination programs or customer accounts, as assigned by senior management team. Act as a senior level point of contact throughout project duration for local and globally scoped deliverables with single/multiple Lifecycle Safety functions. Collaborate with global management team and integrated partners to develop and implement strategic initiatives / solutions and ensure global consistency.Essential Functions• Manage customer interface and communication for large programs or standalone projects. Represent Lifecycle Safety on projects/programs; serve as primary point of contact within Lifecycle Safety for all internal and external customers; liaise between internal/external customers and Lifecycle Safety Operational teams.• Manage customer deliverables for assigned projects/programs. Tactical, day-to-day customer-facing leadership at project/program level. Responsibilities include project planning (timelines, deliverables), scope management, quality management and project financial management.• Act as an account owner over a program or customer portfolio and therefore report program/portfolio level metrics and provide oversight of projects they do not directly lead.• Performs role of solution architect responsible for crafting and defending proposed solutions to new standalone Safety business opportunities. Formulates operational budgetary assumptions and takes decisions to steer the creation of the budget, fulfil required customization of text and data. Acts autonomously as the Safety Subject Matter Expert (SME) and single point of contact for Governance, Executives and Integrated Partners in construction of proposed solution and defends the strategy and pricing from initiation through to delivery.• Represents as Safety SME. Provide leadership and accountability for customer-facing collateral and operational support to deliver key customer messages, working cross-functionally and across the opportunity lifecycle, integrating lifecycle safety core message delivery into customer facing material, presentations and meetings. Collaborate with senior leadership to implement strategic initiatives and ensure global consistency.• Provide leadership structure for customer service interface from scoping stage, through proposal generation, bid defense to transition of work and service delivery; and throughout the development and commercial life cycle of the product.• Attend Joint Operating Committee Meetings and / or Governance meetings to provide portfolio level quality and compliance metrics, to provide other portfolio level updates, and to partner with customers at a Senior Management Level.• Lead internal escalation meetings to ensure quick response to any quality concerns or customer escalations, ensuring appropriate representatives from stakeholders and operational management are involved as appropriate.• Manage finances for assigned projects/programs. Update financial systems, revenue recognition, invoicing, project budget review, project financial analysis, pursuit of change orders, etc.• Ensure financial project performance through oversight of key performance metrics (i.e. revenue, direct costs, time-sheet costs, contribution margin).• Develop specialized expertise across the Pharmacovigilance spectrum (e.g. Global Regulatory, Regulatory reporting requirements), and apply this expertise within assigned projects, and cascade knowledge to PV Solutions team as appropriate• Work with sales and proposals to ensure rapid, seamless, tailored responses to opportunities. Drive business growth by improving customer loyalty through enhanced customer relations, service delivery excellence and excellent customer communication.• Manage start-up of new projects using standard operating procedures and best practices, including identifying potential risks during project initiation and implementing mitigation measures to ensure seamless delivery at maintenance stage.• Lead meetings with internal and external stakeholders. Provide project status updates, defines processes, project/planning strategy.• Provide leadership for Lifecycle Safety virtual project teams: keep local/global Lifecycle Safety team current on project developments; lead internal Lifecycle Safety team meetings to review project processes and status. Work closely with Lifecycle Safety Operational teams, to ensure projects/programs are delivered in accordance with customer expectations• Facilitate sales activities, and sales presentations (capabilities, bid defenses) and proposal development (strategy, costs and text), as needed.• Incorporate strategic options when defining project/program scope and processes with customer• Develop customer relationships into partnerships; manage accounts targeting extended business relationship throughout lifecycle. Focus on customer loyalty and contract renewal. Facilitate discussions on new business opportunities with existing customers.• Work in a customer centric fashion analyzing current and future customer needs and actively developing innovative, cross- functional strategic solutions within Lifecycle Safety service lines to meet customer needs.• Actively contribute during client and internal audits and inspections for assigned project. Liaise with Quality Assurance staff and management in the compilation of corrective action plans• Identify and drive departmental initiatives aimed at enhancing customer service, efficiency, quality, or employee engagement• Represent LS Leadership at select external and internal meetings.• Takes on a higher level of leadership within the department to mentor and support junior leads.• Collaborate with Lifecycle Safety Management to resolve problem areas and customer needs ensuring global consistency• Perform other duties as assignedQualifications• Bachelor's Degree Health science or other directly related field Req• Other Project Management Professional (PMP) Certification Pref• 6 to 7 years' clinical research experience in a Contract Research Organization or Pharmaceutical company combining 6 years of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management etc.) and 3 years' project management experience Req Or• Equivalent combination of education, training or experience Req• In-depth knowledge of applicable global, regional and local clinical research regulatory requirement; i.e.Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, IQVIA Standard Operating Procedures.• In-depth knowledge of Lifecycle Safety service lines; willingness to increase knowledge across Lifecycle Safety service lines and develop new skills.• Strong team management and leadership skills, conflict management.• Strong project management; planning and organizational skills.• Effective verbal and written communication skills including ability to network and lead teleconferences.• Effective collaborative, organizational and delegation skills.• Ability to establish and maintain effective working relationships with coworkers, managers and customers.• Ability to deliver on multiple projects and manage competing priorities.• Ability to manage ambiguity.• Effective business focus, marketing, sales skills.• Proven strong presentation; report writing skills and customer focus skills.• Ability to achieve results through communication, facilitation, negotiations in a matrix service delivery environment with shared accountabilities.• Independent judgment, negotiating, decision-making, and problem-solving skills.• Effective business acumen and financial analytical skills, tactical planning, budgeting.• Customer focused with effective relationship building skills.• Effective motivating, influencing and conflict resolution skills.

**Job Summary**
**The Global Safety Officer (GSO) for Marketed Products serves 2 roles: 1) safety expert of the assigned marketed product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities. The GSO is accountable for the overall safety profile and all product-related decisions and deliverables for assigned marketed products.**
**The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). The GSO also is a member of the Evidence Generation Team. The GSO will be assigned as delegate for the TAH as needed and has management of Global Safety Scientists.**
**Key Activities**
**Applicable tasks may vary by product(s) assigned.**
**Product safety profile, benefit-risk evaluation, and risk communication:**
+ Accountable for the Development and maintenance of core reference safety information (e.g Core safety information portions of Core Data Sheet (CDS))
+ Identify relevant data and conduct benefit-risk evaluation
+ Participate in product label process
**Clinical trial safety:**
+ Develop a strategy as needed for preparing and updating safety related portions of the Informed Consent Form and other study related documents for trials conducted post marketing.
+ Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees
+ Perform signal detection activities for developmental products under the direction of the GSO leading the product in development.
**Signal detection, evaluation, and management:**
+ Develop signal detection strategy
+ Evaluate safety signal detection findings, validate signals and determine a need and develop a strategy for further analysis
+ Decide on need for further actions on safety issues and lead cross-functional discussion
+ Documents work as required in the safety information management system
+ Prepares and presents recommendations on safety issues to the Global Safety Team and escalates as appropriate to the executive level cross-functional decision-making body
+ Approves the safety assessment report
+ May search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
+ Documents work as required in the safety information management system
**Risk management and minimization:**
+ Ensure timely preparation, content, and quality of new or updated risk management plan (RMP) document
+ Develop a strategy for safety risk minimization measures globally (including US REMS if applicable)
+ Develop materials for additional risk minimization measures as applicable to role
**Periodic (aggregate) safety reporting:**
+ Ensure timely preparation and quality of periodic reports (e.g., PSUR/PBRER)
+ Review and approve periodic safety reports
**Safety Governance Leadership:**
+ Participates in safety governance meetings per Standard Operating Procedures and Manuals (e.g. Facilitates, Chairs, Presents)
**Amgen commercialization process:**
+ Represents and contributes on behalf of Global Patient Safety on Evidence Generation Teams
**Inspection Readiness:**
+ Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
+ Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
+ Partnerships and integration activities
+ Participate in safety agreement development and review process
+ Prepare safety information to support licensing partners, review safety documents prepared by licensing partners, and communicate with licensing partners on safety matters per the safety agreement
+ Perform safety due diligence in preparation for partnerships, etc.
+ Participate in integration activities
**Other Amgen processes:**
+ Interact with external stakeholders (e.g., advisory boards) on safety-related topics
+ Prepare for and participate in regulatory agency advisory committees
+ Provide safety input to support legal needs
+ Managerial and supervisory responsibilities
+ Oversees day to day activities of the Global Safety Physician if applicable
+ Ensure staff are compliant with Amgen corporate and departmental training and SOP review
+ Provide training, coaching, mentoring, and development of staff
+ Assist in the recruitment of talented GPS and AMGEN staff
+ Accountable for disseminating and representing corporate and departmental information to staff and ensuring understanding and adherence to changes
+ Development plans for staff created annually and reviewed quarterly
**Education & Experience (Preferred)**
+ Medical Degree (MBBS or MD) required from an accredited medical school with atleast 8 years of relevant experience .
+ Product safety in the bio/pharmaceutical industry/CRO or regulatory agency
+ Previous management and/or mentoring experience
+ Clinical/medical research experience

Qualifications: 
With at least 1 year of clinical/bedside exp
Okay to work on a Shifting Schedule and Onsite

Job Description:
The Occupational Health Nurse (OHN) plays a vital role in promoting and maintaining the health and safety of employees within the workplace.

Job Category: BPO Job Type: Full Time Job Location: Makati Ortigas Taguig

**Description**
**Who is USP?**
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work-an environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity, and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
**Brief Job Overview**
This position functions as Director Facilities, Safety & Administration in the operations leadership position responsible for strategic planning, managing, and implementing facility, safety and security management of USP India laboratory and office operations. In addition, the incumbent will play a key part in administration, soft services, and act as the administrative manager for USP's city office operations. A role where proactiveness is everything and is an opportunity to mentor a highly collaborative and diverse facility, safety, administrative and security team. The incumbent in this role is expected to handle local and global facility related activities and in collaboration with Global Facilities will be expected to plan, implement, and manage strategic facility, business continuity and expansions activities of USP.
**How will YOU create impact here at USP?**
In this role at USP, you contribute to USP's public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments.
+ **Strategic Facility, Safety and Administrative Management Functions.**
+ Should have the capability to independently set up the goals, strategy and tactics pertaining to Facilities, Safety, Administration and Security operations to facilitate seamless operations of USP site needs for all the units of USP which includes R&D, Collaborative Laboratory, Biologics, Synthetics and ITeS operations.
+ Plan, organizes, schedule and directs the design, maintenance, construction, renovation, and repair of USP laboratory set up, administrative set up and city office facilities and equipment. Develop plans and programs that meet present and anticipated laboratory and administrative space and facility requirements. Monitor and inspect all buildings and equipment to ensure that utility systems are operational and that preventive maintenance schedules are being followed. Prepare cost estimates for building renovations or space allocations. Evaluate completed work and checks for conformance to specifications.
+ Establish, develop, and implement office administration strategies and supervising day-to-day operations across multiple locations. Act as the onsite administrative manager and manage day-to-day operations and ensure high quality delivery and facilitation of all office functions and services at USP locations. Ensure the delivery of facility management to the highest standards (meeting rooms, open areas, cafeteria) and identify opportunities to continuously improve all aspects of office operations.
+ Maintain effective relations with all suppliers and service providers (facility management, procurements, stationery, furniture, insurances, etc.) and keep all office equipment operational and maintained.
+ Ensure employees health and safety, office transportation and parking management, cafeteria and office supplies, corporate tie-ups and deals. Planning, scheduling, and promoting office events, including meetings, conferences, interviews, orientations, and training sessions.
+ Prepare and operate department, capex, operational and project budgets and establish effective controls, SLA's and reporting schedules.
+ Establish and implement a strong communication workflow with internal and external stakeholders to ensure seamless integration of facilities team with the laboratory and other site operations teams of USP.
+ **Operational Facility, Safety, Security and Administrative functions.**
+ Engineering Services: Ensure smooth day to day operations, break down and preventive maintenance of all the utility equipment Viz. Chillers, Cooling towers, water systems, HVAC, DGs,ACs, lBMS,Fire hydrant system, Fire detectors etc. and guide the team to achieve an optimal results. Ensure all support services to all the Laboratories are provided without any hindrance. Guide the team on day-to-day energy consumption monitoring. Guide the team on day-to-day water and other consumables consumption monitoring. Ensure effective Spare parts planning and inventory management. Handling of all the AMCs and maintaining schedules as per the AMCs. Handling of any new or modification projects. Capex and Opex preparations. SOPs review and sign off. Lead the team on any new process improvement projects and ensure end to end completion. Technical and commercial discussion of all the projects / material. Technical guidance to the team members on a need basis. Ensuring all AMCs are negotiated and signed off before the due date.
+ Environment, Health & Safety: Leads the development and execution of health & safety, environmental management and strategy for the organization. Drives the establishment of objectives, plans, standards, global procedures and policies ensuring successful implementation and integration of EHS systems at laboratories, offices and administrative areas; determines project timelines with overview of budgets and business workflows. Monitor and evaluate programs and procedures for all facilities that enhance EHS awareness and compliance with state and country regulations as well as corporate guidelines and policies. Coordinate and lead site safety team in respect of environmental audits, assessments and industrial hygiene surveys to ensure compliance with regulatory standards and best practices, as well as established corporate procedures and requirements. Guide the safety team to review all incident investigations and reports. Ensure root causes are determined. Develop and share effective actions to prevent reoccurrence at all USP locations.
+ Staff transport: Monitor staff transport services. Get involved in the transport committee meetings, understand the concerns and resolve them. Keep a track of vehicle running per month and cap the overall monthly mileage. Review contracts and renew them by the due date. Keep track of the vehicle condition, driver behavior, staff safety and conduct trainings by the EHS manager of transport supervisor. Front office management: Ensure professional, polite, disciplined front office management. Guide front office executive on the importance of being a polite receptionist. guide the executive on an effective usage of stationery. Help him/her on the contracts of courier etc. Canteen facility: Conduct food committee meetings. Keep a tab on the food quality and hygiene by collecting feed backs from the employees. Conduct regular meetings with the vendor to keep brushing him up on the quality of the services. Housekeeping: Help the Admin manager to develop more effective housekeeping protocols & schedules. Ensure periodic checking of the protocols and schedules. Have proper control over inventory of housekeeping material.
+ Security: Ensure security and EHS managers conduct trainings on regular basis on ERP & the security aspects. Check for correctness and accuracy of all records and documents pertaining to security. Check the visitor management register maintained by the security. Ensuring all the service agreements are negotiated and signed off before the due date. Act as liaison and mange outside contractors responsible for facility operations
**Who is USP Looking For?**
The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
+ Master's degree in mechanical/chemical engineering and appropriate Facilities Management certifications or accreditations. Candidates having additional qualifications like a master's degree in business administration or any other management grade certification will be preferred.
+ Minimum of 15-20 years of experience in a facility management role.
+ Minimum 15 years of people management experience
+ Self-motivated, takes initiative and effectively organizes, multi-tasks and prioritizes a wide array of initiatives in a fast-paced environment.
**Additional Desired Preferences**
+ Prior experience in pharmaceutical and scientific R&D industry.
+ Results driven with demonstrated successful outcomes.
+ Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner.
+ Ability to handle multiple priorities in a fast-paced environment.
+ Excellent written and verbal communications skills.
+ Able to work flexible hours when needed. In addition to normal business hours serves on the Emergency Response Team to provide 24 hour a day, 7 days a week response to emergency alarm calls and can be available on short notice to support requests during unusual hours, especially early or late in the day during the business week.
**Supervisory Responsibilities**
A team of 5 to 10 staff.
**Benefits**
USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.
Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
**Job Category** Administrative
**Job Type** Full-Time

Position Details:

- Qualification: MBBS with AFIH certification (mandatory)
- Experience: Preferably 5 - 10 years in industrial health or a similar role

Key Responsibilities:

- Conduct periodic medical examinations of employees
- Provide first-aid and emergency care onsite
- Ensure statutory compliance with health-related regulations
- Liaise with external medical facilities and government health authorities
- Support health awareness and preventive programs within the workplace

Pay: ₹120,000.00 - ₹125,000.00 per month

Work Location: In person

Are you a passionate and experienced nurse looking for a dynamic opportunity? Nezda is currently seeking dedicated individuals to join our team as an Occupational Health Nurse / Company Nurse.

Qualifications:
Minimum of 1 year of clinical (bedside) experience
Willingness to work on a rotating shift and onsite

Job Description:
Effectively maintain and provide the highest level of medical and primary emergency care in emergency cases for all personnel at the designated site in line with Medical Services clinical guidelines.
Participate in the development and maintenance of a safe and healthy workplace.
Undertake all mandatory OH&S training as required.

Salary: P23,000 P28,000

Job Category: BPO Job Type: Full Time Job Location: BGC Laguna Pasay