Pharmacovigilance Specialist / Assistant

Kaav Inc.

Job Title: Pharmacovigilance Specialist / Assistant

Location: Remote (Candidates in Fort Worth, TX or Boston, MA preferred for future hybrid)

Job Summary:

seeking a Pharmacovigilance Specialist to support adverse event case processing and safety reporting . This role is highly interactive and requires working closely with patients, healthcare professionals (HCPs), vendors, and internal teams .

The ideal candidate will have strong experience in drug safety, case processing, and regulatory compliance (FDA/Health Canada) , along with the ability to operate in a fast-paced, high-volume environment .

Key Responsibilities:

Adverse Event Case Management (50%)

Review and evaluate incoming communications (phone, email, fax, etc.) for adverse event (AE) reporting
Perform medical evaluation of AE cases for seriousness and reporting requirements
Process and manage cases in safety databases (e.g., ARGUS )
Conduct follow-ups to gather missing or additional case information
Prepare and submit expedited and periodic safety reports to FDA and Health Canada
Ensure AE intake from marketing programs and social media platforms
Support audits and regulatory inspections
Perform trend analysis and signal detection reporting

Regulatory & Product Knowledge (25%)

Maintain knowledge of FDA & Health Canada pharmacovigilance regulations
Understand company SOPs, drug safety processes, and compliance requirements
Develop knowledge of Galderma products and dermatology-related conditions

Data & Case Tracking (15%)

Maintain and update case tracking systems and databases
Perform reconciliation with Medical Information, Quality, and external partners

Training & Support (10%)

Develop and deliver training on adverse event reporting
Support onboarding of new employees and vendors
Assist in SOP creation and process documentation

Required Qualifications:

Bachelor's degree in Life Sciences, Healthcare, or related field
5+ years of Pharmacovigilance / Drug Safety experience
Strong experience in case processing and adverse event reporting
Knowledge of FDA and Health Canada safety regulations
Hands-on experience with ARGUS or similar safety databases
Strong understanding of medical terminology and drug safety concepts
Ability to handle patient and HCP interactions (including sensitive discussions)

Preferred Qualifications:

RN, PharmD, or other healthcare certification
Experience with biologics, drugs, or combination products
Background in CROs or Pharma/Biotech companies
Experience in SOP writing and training delivery
Exposure to global pharmacovigilance environments

Top Skills Required:

Pharmacovigilance & Adverse Event Case Processing
FDA / Health Canada Regulations
ARGUS Safety Database
Strong communication with patients & HCPs
Critical thinking & escalation judgment

Soft Skills:

Self-driven and able to work independently in remote setup
Strong communication and collaboration skills
Ability to handle high-volume workload and prioritize effectively
Comfortable in externally facing, high-visibility role

Nice-to-Have Background:

CROs: IQVIA, Parexel, ICON, Syneos, PPD, Labcorp
Pharma/Biotech: Pfizer, Amgen, Novartis, AbbVie, Merck

Interview Process:

Round 1: Hiring Manager (Nancy Dubois)
Round 2: Senior Pharmacovigilance Team

Additional Notes:

Immediate need due to high case volume and understaffing
Role is highly visible and interactive , not just backend processing
Potential for future conversion (must be open to hybrid in TX or MA )

Apply

Vacancy posted 2 days ago

Similar jobs that could be interesting for youBased on the Pharmacovigilance Specialist / Assistant in Boston, MA vacancy

Intake Specialist/Medical Receptionist
...Intake Specialist/Medical Receptionist Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations... ...any questions, addressing their concerns and providing assistance. It is important that this role be the relationship bridge between...
Suggested
Full time
Temporary work
Work at office
Alcanza Clinical Research
Roslindale, MA
2 days ago
Senior Specialist, Program Scheduler
$84k - $156k
...domains in the interest of national security. Job Title: Senior Specialist, Program Scheduler Job Code: 40492 Job Location:... ...insurance, 401(k) match, flexible spending accounts, EAP, education assistance, parental leave, paid time off, and company-paid holidays. The...
Suggested
For subcontractor
Local area
Flexible hours
L3Harris Technologies
Dorchester, MA
4 days ago
Senior Specialist, Drug Safety
...Position SummaryReporting to the Head of PV Ops, the Senior Specialist, Drug Safety will support individual case safety report (ICSR... ...healthcare profession.Prior experience working on a nimble Pharmacovigilance Team in Biotech or small/medium size pharmaceutical company....
Suggested
Remote work
Crispr-Therapeutics-1
Boston, MA
1 day ago
Night Auditor & Front Desk Specialist
La Quinta Boston - Somerville is seeking a Night Auditor to reconcile cashier transactions, compile reports, and ensure accuracy of guest billings and city ledger transactions. The role includes guest service duties such as check-in/check-out and reservations, with a focus...
Suggested
Night shift
Afternoon shift
Highgate Hotels
Somerville, MA
1 day ago
Night Auditor & Front Desk Specialist
AC Hotel Boston Cambridge is seeking a Night Auditor to balance nightly accounts, perform routine front desk tasks, and prepare daily financial reports. You will audit cashiers, reconcile credit cards, and update the BRAINS network while ensuring guest satisfaction. The...
Suggested
Flexible hours
Night shift
AC Hotel Boston Cambridge
Cambridge, MA
4 days ago
Remote Virtual Assistant & Admin Specialist
A leading recruitment firm is seeking a responsible Virtual Assistant to work remotely or onsite, focusing on organization, communication, and technology use. Tasks include managing communications, preparing reports, and creating presentations. Ideal candidates should have...
Remote job
Recruit Monitor
Boston, MA
2 days ago
Intake Specialist/Medical Receptionist
...general medicine. Join us as we continue to grow. The Intake Specialist is the first point of contact at the site making this a... ...answering any questions, addressing their concerns and providing assistance. It is important that this role be the relationship bridge between...
Full time
Temporary work
Work at office
Alcanza Clinical Research
Roslindale, MA
a month ago
Drug Safety Specialist
...Job Description The client is looking for a Drug Safety Specialist with 3 5 years of pharmacovigilance experience and a clinical background (e.g., RN, BSN,... ...surveillance for marketed and investigational products. Assist with the identification and evaluation of events of...
Contract work
3 days per week
Talent Groups
Waltham, MA
5 days ago
Night Auditor & Front Desk Specialist
Colwen Management Inc is seeking a Night Auditor for the Residence Inn by Marriott Natick. This full-time overnight position involves balancing hotel transactions, responding to guest requests, and maintaining the front desk area. The ideal candidate will have hotel experience...
Full time
Night shift
Colwen Hotels
Natick, MA
5 days ago
Drug Safety Associate
...and Benefit Risk, Global Case Management department performs pharmacovigilance activities, ensuring timely adverse event reporting in compliance... ...the direction of a manager, to meet department objectives or assist on special projects within established deadlines....
Careers Integrated Resources Inc
Cambridge, MA
2 days ago
Associate Research Fellows (Two Positions Available)
$90k - $96k
Ibis Reproductive Health is a global nonprofit driving change through bold, rigorous research, and principled partnerships that advance sexual and reproductive autonomy, choices, and health worldwide. We believe that research can catalyze change when the entire research...
Temporary work
Work experience placement
Work at office
Remote work
Worldwide
Shift work
Wisconsin Psychiatric Association
Cambridge, MA
7 days ago
Associate/ Research Associate
Synapse Energy Economics is a research and consulting firm specializing in energy, economic, and environmental topics with a focus on resource and policy issues in the electric industry. Our work supports a broad range of public-interest clients, including consumer advocates...
Work at office
Flexible hours
Synapse Energy Economics
Cambridge, MA
4 days ago
Demand Generation Specialist
$75k - $85k
...Demand Generation Specialist The Role OpenClinica is seeking a data-driven Demand Generation Specialist to support pipeline growth and lead generation across key customer segments, including biotechnology companies, CROs, academic research institutions, healthcare...
Remote work
OpenClinica
Needham Heights, MA
5 days ago
Senior Safety Specialist
...The Senior Safety Specialist is a highly experienced field and systems-based safety professional responsible for supporting, implementing... ...systemic improvements. Safety Systems and Performance Management Assist in maintaining safety KPI dashboards and performance metrics....
Work at office
Feeney Brothers
Boston, MA
4 days ago
Mental Health Specialist (full-time)
...Mental Health Specialist (Full-Time) Mental Health Specialists partner with the clinical team to provide therapeutic care and help create a safe, structured, and supportive environment for children, adolescents, and families. In this role, you will build skills in...
Full time
Temporary work
Night shift
Afternoon shift
Franciscan Children's
Brighton, MA
1 day ago
Milieu Behavior Specialist
...throughout the city. The Position The Ivy Street School is seeking a full-time, M-F 40 hour a week Milieu Behavior Specialist to participate as a member of the Behavior Department. The Milieu Behavior Specialist will take a leadership role in crisis prevention...
Full time
Immediate start
Monday to Friday
MAB Community Services
Brookline, MA
5 days ago
Safety Specialist
$70k - $80k
...Job Title: Safety Specialist Location: Quincy MA Type: Direct Hire Compensation: $70,000.00 - $80,000.00 Hours: Monday - Friday 7:00 AM... ...OSHA standards are met and industry best practices are followed. Assist with Job Hazard Analysis reviews and create safety education materials...
For contractors
Work at office
Local area
Monday to Friday
Afternoon shift
System One
Quincy, MA
2 days ago
Shareholders & Incentives - COE Solution Specialist
$145k - $250k
...Job Description The Shareholder & Incentives Solution Specialist within the Total Reward Center of Excellence is responsible for the strategy, design, and governance of performance-based incentive and equity programs that align employee outcomes with the DPR’s long-term...
Work experience placement
Work at office
Local area
DPR Construction
Boston, MA
2 days ago
Specialist Supply Chain Sustainability
$66k - $99k
...lifetime. At Hasbro, we believe responsible sourcing strengthens our business and our communities. The Supply Chain Sustainability Specialist supports this mission by helping advance ethical sourcing, human rights, and social compliance across our global supply chain. In...
Temporary work
Interim role
Worldwide
Hasbro
Boston, MA
4 days ago
Recovery Specialist
$22 per hour
...Join BHN as a Recovery Specialist at our Clinical Stabilization Service (CSS) in Hyde Park! Why Choose BHN: Work with a mission-driven agency making a difference every day Gain valuable experience in substance use and recovery services Opportunities...
Hourly pay
Daily paid
Shift work
Behavioral Health Network
Boston, MA
3 days ago
Family Specialist
$21 - $23 per hour
...Family Specialist Child Care Circuit - 01840, MA 01840 Overview Salary Range $21.00 - $23.00 Hourly Position Type Full Time Category Family Services Description The Family Specialist provides support and counseling to families regarding state financial...
Hourly pay
Full time
Local area
The Community Group
Boston, MA
4 days ago
Developmental Specialist - Early Intervention
$51k - $56k
...Family Services located in Boston, MA is seeking a Developmental Specialist/Early Childhood Educator to join their team. As an... ...timelines are followed. Provides supportive professional assistance to families. Facilitate parent-child interactions to...
Daily paid
Temporary work
Work experience placement
Work from home
Flexible hours
Thom Child & Family Services
Jamaica Plain, MA
5 days ago
Vocational Specialist
$58k - $62k
...Best Workplaces in Financial Services & Insurance Vocational Specialist Candidates must hold an active Certified Rehabilitation... ...medical/clinical or rehabilitation knowledge and experience to assist in the management of accommodations, restrictions, and rehabilitation...
Remote work
Flexible hours
Sedgwick
Boston, MA
1 day ago
Musketeer - On Premise Specialist
Qualifications Established contacts within the industry, or the ability and desire to develop them quickly and smoothly Experience in the beverage industry, gastronomy, hospitality and catering, marketing, sales, or as your own boss is highly preferred Strong ability to...
Permanent employment
Flexible hours
Weekend work
Afternoon shift
Red Bull North America
Boston, MA
5 days ago
Prior Authorization Specialist
$20.5 - $27.59 per hour
...appropriate systems. (essential) 5. Completes assigned work queues and reports daily to achieve standards of productivity and quality. Assists with reviewing medical necessity and obtaining authorization for urgent or walk-in visits. Refers patients to financial counselors...
Hourly pay
Work experience placement
Interim role
Immediate start
Shift work
Beth Israel Lahey Health
Boston, MA
1 day ago
Outreach Specialist
$23.48 - $26 per hour
...of Boston SUMMARY OF THE POSITION : The Outreach Specialist will provide outreach, engagement, and case management services... ...Outreach Specialist will assess individuals on the streets, assisting with identifying the appropriate level of service need and diverting...
Hourly pay
Full time
Monday to Friday
Weekend work
Afternoon shift
Pine Street Inn
Boston, MA
5 days ago
EHS Specialist (Regulated Industry)
...health and safety standards. Establish and maintain effective relationships with Operations, Managers, Supervisors and employees. Assist in the oversight of the Worker's Compensation program. Promote excellent relationship with MENTOR clients, encouraging an open dialog...
Local area
Mentor Technical Group
Boston, MA
5 days ago
Junior Motion Capture Specialist
$62.3k - $92.4k
...Description CD PROJEKT RED is looking for a Junior Motion Capture Specialist to join our team in the Boston hub as we continue to build the... ...animation quality across our projects. Daily Responsibilities Assisting in all stages of a mocap shoot. Processing mocap data:...
Full time
Casual work
Work at office
Home office
Flexible hours
CD Projekt RED
Boston, MA
2 days ago
Commissioning Specialist
...comprised of architects and engineers providing specialty services to support our clients and projects. As a Commissioning & Energy Specialist on our team in Boston you will participate in both onsite and office activities to support Commissioning and Energy projects....
For contractors
Work at office
Jacobs
Boston, MA
3 days ago
Safety Specialist II
...Safety Specialist II – Full time – Boston, MA 02210. Base pay: $71,800 – $119,600. Overview Creating a better way to live is the purpose that binds AvalonBay associates. We take that purpose seriously and expect you will, as well. By focusing on collaboration, innovation...
Full time
For contractors
Local area
Immediate start
XCORP AvalonBay Communities Inc.
Boston, MA
3 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Pharmacovigilance Specialist / Assistant. Be the first to apply!