Safety Surveillance Associate Job at Pfizer (Makati City)

Associate Director, Pharmacovigilance Scientist

The Associate Director, Pharmacovigilance Scientist will provide leadership, gui...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

A minimum of 10+ years of experience in global pharmacovigilance in pharmaceutical, biotech, or CRO setting with a Bachelors degree or 5+ years of experience with an advanced degree
Experience in safety data analysis, signal management, and benefit-risk evaluation
Knowledge of safety databases (Argus, ArisG/LifeSphere Safety, Veeva or similar), ICSR workflows, and MedDRA coding
Experience with authoring or contributing to aggregate safety reports, signal assessment reports
Working knowledge of relevant local and global regulatory requirements and guidance documents
Experience in creating or managing SOPs or Work Instructions
Strong ability to proactively identify signals, trends, risks, and initiate/manage risk minimization activities
Strong ability to work independently and collaboratively with internal and external partners in a demanding environment
Ability to prioritize, multitask, and deliver quality results that meet tight timelines
Fluency in written and spoken English with strong ability to communicate complex issues clearly

Job Responsibility

Perform and coordinate complex benefit-risk assessment and safety surveillance activities
Serve as a critical contributor to the safety governance framework, prepare safety data for review, coordinate and attend Safety Management Team and Medical Safety Board meetings
Coordinate and support strategies for safety assessments in collaboration with the safety physician and medical development as applicable
Lead and contribute to the management of aggregate safety reports (e.g., DSURs, PBRERs, PADERs, periodic line listings) including scheduling, planning, and authoring assigned sections
Collaborate with cross-functional teams to regularly review emerging safety data for the purposes of trend analysis and/or signal detection as applicable
Contribute to the preparation of queries in the safety database, retrieve and present data for regular and ad-hoc safety reviews
Perform safety signal management activities
conduct signal detection, author signal validation/evaluation reports, track and communicate findings
Collaborate cross functionally to access and utilize data visualization and analysis tools for regular and ad-hoc safety reviews
Lead or assist with the preparation of Risk Management Plans (RMPs)

What we offer

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

Fulltime

Mechanical Planner

Airswift is seeking a Mechanical Planner to support the nuclear industry in an i...

Location

United States , Richland

Salary:

Not provided

Airswift Sweden

Expiration Date

Until further notice

Requirements

Able to communicate effectively in writing and orally
Strong computer skills
Able to troubleshoot and solve technical problems
Able to obtain Planner I qualification
Working knowledge of: Nuclear power plant work management and planning process. Safety regulations associated with a power plant environment. ALARA requirements. Nuclear Security operations, regulations, and requirements
A bachelor's degree from accredited college or university and a minimum of six years of experience in a technical area (i.e. maintenance, engineering, operations, Maintenance Planning)
OR An associates degree from an accredited college or university and eight years of experience in a technical area (i.e. maintenance, engineering, operations, maintenance planning)
OR A high school diploma or GED and technical training or education similar to that acquired through an in-grade apprenticeship program for maintenance related work and six years of experience in a technical area (i.e. maintenance, engineering, operations, maintenance planning)
OR A high school diploma or GED and ten years of experience in a technical area (i.e. maintenance, engineering, operations, maintenance planning)

Job Responsibility

Manage work activities of maintenance craft through planning, leading, and monitoring to ensure that work is executed in an efficient and safe manner. This includes all aspects of physical plant work including work package preparation, parts procurement, ALARA briefings, clearance order walk downs, work prioritizing, resource loading and work execution, including resolution of schedule delays and conflicts
Prepare for scheduled and emergent work. This is accomplished through interface with planning personnel, evaluating adequacy of work instructions by paper review and physical plant walk downs, resource loading work in accordance with available manpower and qualifications, reviewing schedules for adverse impacts such as availability of test equipment and parts, and staging the job site to ensure timeliness of work completion
Implement work efficiently and effectively. This is accomplished through pre and post job briefs, supervising work in progress, providing coaching and feedback on individual and crew performance, and monitoring work to ensure it is conducted in accordance with procedures and management expectations. These expectations include good ALARA performance, nuclear and personnel safety, the use of proper communication and performance techniques, error free quality work, and adherence to procedures. This is measured through a routine of observing and assessing work sites to assure that problems and coordination issues are being resolved in the field in a timely manner to maximize work crew field time on the job
Review of work documentation prior to the close out of work package(s) to ensure accuracy and completeness and that the work objectives have been met
Establish and monitor individual performance and training plans for crewmembers and provide critical feedback on a situational and periodic basis
Monitor performance through maintenance indicators and take action as appropriate to continuously improve work process efficiencies
Specific accountabilities with measurable performance indicators include human performance, work order back log relative to discipline, daily and weekly schedule effectiveness, preventative maintenance back log, maintenance productivity, dose associated with work activities, and surveillance procedure completion
Assure proper training of assigned personnel through the observation, evaluation, and feedback of training classroom, laboratory, and on-the-job training and evaluation activities
Provide training as a classroom instructor on a minimum of two subject matters
Position may require periodic assignment to Training as an instructor

Post-Market Compliance Specialist III- Autoimmunity

The Post-Market Compliance Specialist III supports product complaint management ...

Location

United States , San Diego

Salary:

80000.00 - 110000.00 USD / Year

werfen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in biological science, biochemistry, or similar field required
Master’s degree preferred
Proficient knowledge of IVD post-market quality system requirements and complaint handling
Advanced knowledge of global IVD post-market regulations and standards
Advanced knowledge with IVD reagents and diagnostic platforms, such as immunoassays, ELISA, chemiluminescent assays, and bead-based multiplex assays on automated systems
Advanced understanding of the functional and performance principles of IVD products, including reagents, calibrators, controls, software, and instrument systems
Minimum of six (6) years of experience in IVD industry in complaint handling, regulatory function, or a closely related technical function, required
Minimum of four (4) years of experience in Autoimmunity IVD, required
Minimum of four (4) years of hands-on laboratory testing of IVD assays including operation of automated IVD instrumentation, execution of test protocols, analysis of test results, and documentation of activities and results, required
Minimum of four (4) years of experience in customer interface responsibilities and complaint handling in an IVD regulated function, required

Job Responsibility

Complaint Management: Intakes, assesses for regulatory reportability, and triages assigned complaints. Designs and executes complex experiments and performs complex complaint investigations including investigation approach determination, experimental design, testing, analyses, and resolution. Triages investigations to other internal departments or manufacturers as needed and follows up with the escalated parties until complaint resolution. Communicates throughout the complaint investigation process from intake to final resolution with customers, affiliates, and internal stakeholders. Presents product issues which should potentially be brought to the Quality Review Board or Field Action Board to PMC management. Prepares presentations and presents issues to QRB and FARB
Laboratory Organization: Maintains laboratory cleanliness and organization. Performs routine cleaning and complete required documentation. Monitors and maintains inventory levels of laboratory test samples, consumables, reagents, and other materials. Ensures laboratory equipment and tools equipment maintenance, calibration, service, and software versions are current
Tracking and Trending: Conducts complaint trend analyses and coordinates the preparation of post-market surveillance (PMS) reports. Prepares Management Review slides on PMS for department management
Field Actions: Authors field action assessments and ensures completion of Health Hazard Evaluations (HHE/HHA) and leads recalls, Field Safety Corrective Actions (FSCAs), Field Safety Notices (FSNs), and associated regulatory notifications
Reportable Events: Completes, files and follow ups on reportable events to regulatory authorities
Department Procedures: Assists in drafting, implementing, and maintaining departmental procedures, work instructions, and templates
Provides technical guidance and mentoring to junior staff. In consultation with department management, develops and executes training for new and developing staff
Complies with applicable standard operating procedures, applicable standards and regula-tions, as well as applicable Environmental Health & Safety, Human Resources and other regulatory and administrative policies
Demonstrates Werfen values through the quality of work and professional working relationships
Other duties as assigned

What we offer

medical, dental, and vision insurance
401k plan retirement benefits with an employer match
paid vacation and sick leave
sales roles are eligible for participation in a commission plan
management and select professional roles are eligible for a performance-based bonus

New

Security Support Specialist

We are looking for a Security Support Specialist to join our Baptist South team....

Location

United States , Jacksonville

Salary:

Not provided

Baptist Health (Florida)

Expiration Date

Until further notice

Requirements

Less than 1 year Security Officer Experience
High School Diploma Required
International Association for Healthcare Security and Safety (IAHSS) Safety Certification Preferred
Healthcare Experience Preferred

Job Responsibility

Provides logistical and technical support to the Safety & Security department by running the visitor management systems
Assisting Security Officers with investigations by reviewing of video surveillance systems and access control logs
Assists with access controls systems & checking in visitors
Create badges for the system
Conduct fire extinguisher inspections
Data entry for parking violations and support the Safety & Security department as directed by the Executive Director of Safety & Security

Fulltime

Patient Safety Associate

Deliver Excellence in Pharmacovigilance. Join Our Patient Safety Team as a Patie...

Location

Australia , Melbourne, Sydney

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Health Science degree or equivalent
Minimum 3 years of experience in a drug safety or equivalent role in a highly regulated industry e.g., pharmaceutical or devices
Good working knowledge of the regulatory requirements for managing and reporting adverse events in Philippines
Experience in clinical trial pharmacovigilance
Understanding of the applicable Australia, New Zealand and EU requirements
Highly developed service, communication, organisational and problem-solving skills
High level of attention to detail and computer literacy with experience in safety database (Argus, ARISg, Veeva Safety)
Practical experience in SOP writing and document management

Job Responsibility

Act as part of PS & RM Team in line with the scope of the project to meet project outcomes and deliverables ensuring compliance
Work within the systems and processes designed to meet Good Pharmacovigilance Practices (GVP)
Ensure that all potential adverse events or product complaints associated with adverse events, are appropriately reported and followed up according to client procedures
Evaluate adverse events & follow up reports received from various channels and assesses seriousness based on criteria
Process & report safety data as per SOP and client instructions to maintain client and regulatory compliance
Maintain the integrity of client safety data registered into the safety databases
Participate in internal and external audits
Perform literature surveillance and regulatory authority adverse event searches
Assist the Project Manager or the Patient Safety Manager/ Senior Manager as requested (e.g. to provide input to SOPs or Safety Data Exchange Agreements)

What we offer

Work with a diverse range of clients across medicines, vaccines, and medical devices, expanding your technical expertise and making a meaningful impact in Patient Safety across multiple therapeutic areas
Enjoy a flexible, hybrid work model and commitment to work-life balance
Join a company that values expertise, excellence, collaboration and continuous improvement

Fulltime

Hp surveyor

To perform activities and carry out assessments on tasks, equipment or environme...

Location

United Kingdom , Nationwide

Salary:

Not provided

NSG Environmental Ltd

Expiration Date

Until further notice

Requirements

NVQ Level 2 Radiation Protection or City & Guilds – Radiation Safety Practices
Proven experience of health physics surveillance
Understands radiological issues, radioactive shielding and barrier theories and protocols for safe working
Working knowledge of Health & Safety Regulations inc: COSHH, PUWER, LOLER, RIDDOR
Compliance with Radiological Protection/IRR 99
Carry out simple arithmetic calculations
Utilisation of technical or scientific data
Must have DV Security Level Clearance
Willing to travel and work away from home as required

Job Responsibility

Perform activities and carry out assessments on tasks, equipment or environments, which have radiological impact
Ensure compliance with Ionising Radiation Regulations 2017 (IRR17) and as instructed by the Radiation Protection Supervisor [RPS]
Response checks of instrumentation
Monitoring of personnel and areas
Designated area access / egress control
Air sampling
PPE / RPE inspection
Possible use of specialised RPE, i.e. PBASO (pressurised breathing air suit operative)
HP monitor support for demolition and remediation project
Working party compliance with radiological controls

What we offer

Support for professional development
Exciting and challenging work environment
Supportive and collaborative working environment

RN, Finger Lakes Occ Health Pgm

Provides direct support for Finger Lakes Occupational Health Services. Plans and...

Location

United States of America , Rochester

Salary:

35.35 - 45.96 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor's degree in Nursing and 1 year of nursing experience required
Master's degree in Nursing preferred
Or equivalent combination of education and experience
3 years of nursing experience preferred
Multidisciplinary knowledge base, including but not limited to, Nursing science, Medical science, Occupational medicine, Epidemiology, Toxicology, Safety, Industrial Hygiene, Ergonomics, Social and Behavioral sciences and Business principles required
Strong process orientation required
Proficiency in MS Office applications required
Excellent communication skills required
Ability to work well in an interdisciplinary setting required
Basic knowledge of wound care and dressings required

Job Responsibility

Provides direct support for Finger Lakes Occupational Health Services
Plans and provides patient/client care and case management services
Develops and provides workplace programs and outreach to the community of occupational and environmental health and safety
Works collaboratively with clinical staff and physicians by planning, providing, and evaluating the care of patients/clients
Performs various tests following OSHA guidelines
Administers immunizations, provides patient educational material, and orders medical/pharmaceutical supplies
Provides direct patient care
Escorts patients to exam rooms
Reviews patient charts to anticipate health needs and organize flow
Obtains and records patient vital signs

Parttime

Operator I, Chemical - Rotational Shift

As an Operator I-Chemical - Shift 1 - Rotation, you will play a crucial role in ...

Location

United States of America , Guayama

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Technical Diploma or Associate Degree with zero (0) to one (1) year of experience
Basic cGMP Knowledge
Proficiency in computer applications including Word, Excel, and PowerPoint
Ability to operate electronic equipment efficiently
Outstanding record-keeping skills
Flexibility to work rotation shifts, weekends, and holidays
Competence in interpreting and applying maintenance, repair, inspection, and compliance codes or standards
Ability to interpret and convert units of measure such as temperature, pressure, flow, area, mass, distance, and volume
Mathematical reasoning skills to perform calculations (addition, subtraction, multiplication, division, and percentage) and use calculators or other associated electronic equipment
Capacity to follow written procedures and verbal instructions communicated via telephone or shortwave radios

Job Responsibility

Complete each specific job assignment in a safe and acceptable quality manner within the expenditure of time and material, adhering to all safety and GMP regulations
Thoroughly document manufacturing activities and make revisions to required documentation (MBRs, LIMS, protocols, SOPs, Forms, Cleaning, EOA, etc.)
Attend manufacturing process trainings
Coordinate process material transfers between control rooms and field operators, including Tank Farm, Environmental, and Manufacturing Areas
Follow the plant safety program and attend training related to Emergency Response Brigade, Log Out Tag Out (LOTO), Work Permit, and Medical Surveillance
Complete manufacturing reports (Mass Balance, Visual Board, Downtime, OEE, Lot Required)
Detect, react promptly, and notify abnormal operating conditions
Perform field troubleshooting
Apply basic product and process knowledge to support manufacturing shifts, including overtime when requested by management
Be an active member of the Emergency Response Brigade, attending required training and Medical Surveillance requirements associated with the Brigade

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Fulltime

Safety Surveillance Associate

Pfizer

Location:
Philippines , Makati City

Category:
Health and Beauty

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 20, 2026

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