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

New

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

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

New

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

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

New

Drug Safety Associate

At Pfizer, our Worldwide Safety colleagues are pivotal in bridging evidence-base...

Location

Taiwan , Taipei

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Pharmacy or Medical
Strong skills in productivity, organizational and time management in order to meet strict regulatory compliance goals
Fluent in spoken and written English

Job Responsibility

Monitor the company's drug, biologics, and medical devices surveillance program
Intake, evaluate, and process adverse reports for both clinical trials and post-marketing activities
Make decisions within limited options to resolve problems, under the supervisor's direction
Work in a structured environment, following established procedures
Ensure work is regularly reviewed for technical judgment, completeness, and accuracy
Provide expertise on regulatory requirements and corporate policies for regulatory submissions to project teams
Support Worldwide Strategy and Regulatory teams by analyzing post-marketing safety data, reviewing medical literature, and related activities
Determine the appropriate workflow for case processing by reviewing case criteria

Fulltime

New

Field Service Representative

We are looking for a motivated Field Service Representative that can work with l...

Location

United States , Cannon AFB, New Mexico

Salary:

Not provided

AEVEX Aerospace

Expiration Date

Until further notice

Requirements

Completion of training requirements mandated by customer
The ability to read and interpret schematics, drawings and block diagrams
Requires extensive experience with stated systems, preferably with AEVEX systems hardware in service with DOD agencies worldwide
Experience in troubleshooting, operation, modification and inspection methods relative to the installed systems is essential
Excellent communication skills, both oral and written
Bachelor’s degree in a related field or 2-6 years of related experience
2-6 years of relevant experience required
Ability to obtain/maintain a Secret DoD clearance, U.S. Citizenship required
Frequently required to stand for extended periods of time
Frequently required to lift up to 15 pounds

Job Responsibility

Performs all matters pertaining to the daily maintenance and inspection
The primary task is that of an avionic system or mechanic system Field Service Representative
Provides CONUS M-Systems Field support for mission systems maintenance
Provides OCONUS deployment support
Advise on logistics and operation of advanced electronic/electro-optic (EO)/radar avionics systems and laser operation
Provide on-site/on-equipment engineering assistance and technical advice including troubleshooting, engineering analysis and interpretation of results to customer personnel
Assist with all aspects of equipment operations including installation, maintenance, operation techniques, adjustment, calibration, trouble shooting, bench check, routine maintenance, inspection and intermediate level repair
Provide advice in the identification of, and instruction on the use of special tools, handling equipment and test equipment associated with avionic systems
Provide advice and assistance on the use of and interpretation of Technical orders, Engineering Change Proposals and other related technical publications
Provide on-going surveillance of shop maintenance and safety practices, provide technical advice and recommend corrective measures necessary to ensure adequate maintenance and safety procedures are followed to minimize future problems

What we offer

401(k)-retirement plan
comprehensive Medical, Dental, Vision, Disability and Life insurance group coverage with a portion of the premiums paid by the company
professional development funds
an Employee Assistance Plan (EAP) with counseling, legal help, child and elder care support

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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