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%)
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
- 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
- Maintain and update case tracking systems and databases
- Perform reconciliation with Medical Information, Quality, and external partners
- Develop and deliver training on adverse event reporting
- Support onboarding of new employees and vendors
- Assist in SOP creation and process documentation
- 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)
- 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
- Pharmacovigilance & Adverse Event Case Processing
- FDA / Health Canada Regulations
- ARGUS Safety Database
- Strong communication with patients & HCPs
- Critical thinking & escalation judgment
- 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
- CROs: IQVIA, Parexel, ICON, Syneos, PPD, Labcorp
- Pharma/Biotech: Pfizer, Amgen, Novartis, AbbVie, Merck
- Round 1: Hiring Manager (Nancy Dubois)
- Round 2: Senior Pharmacovigilance Team
- 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 )
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Pharmacovigilance Specialist / Assistant in Boston, MA vacancy
- ...Pharmacovigilance Specialist / AssistantLocation: 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...SuggestedRemote work
Kaav Inc.
Boston, MA5 days ago - ...and general medicine. Join us as we continue to grow. Intake Specialist is the first point of contact at the site making this a crucial... ...answering any questions, addressing their concerns and providing assistance. It is important that this role be the relationship bridge...SuggestedFull timeTemporary workWork at office
ActivMed Practices & Research, Inc.
Boston, MA3 days ago - ## Senior Specialist, Drug SafetyApplyremote type: Site Basedlocations: South Boston, MAtime type: Full timeposted on: Posted 11 Days... ...profession.* Prior experience working on a nimble Pharmacovigilance Team in Biotech or small/medium size pharmaceutical company....SuggestedRemote work
Crispr Therapeutics AG
Boston, MA5 days ago - ...Intake Specialist Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in AL, AZ, FL,... ...answering any questions, addressing their concerns and providing assistance. It is important that this role be the relationship bridge...Suggested
$60 - $63 per hour
...Senior Technical Recruiter at Talent Group The Pharmacovigilance Scientist will support safety surveillance and signal management activities across clinical and post-marketing products. This role partners closely with PV Physicians and cross-functional teams to manage...SuggestedContract workTalent Groups
Waltham, MA3 days ago$89.59k - $197.46k
...excellence, delivers meaningful impact, and empowers you to shape your own future.KPMG is currently seeking a Senior Associate, Credit Specialist to join our Audit practice.Responsibilities:Execute the day-to-day activities of credit specialist component of audit engagements...Local area$100k - $145k
...corporations and individuals worldwide.About the TeamThe Portfolio Specialist Team is a strategic function within Eaton Vance Equity, part of... ...Funds and other Eaton Vance Equity investment strategies.Assist in responding to client, consultant, and distribution partner requests...Temporary workWork at officeWorldwide$30 per hour
...Job Description Job Description Job Title: Bar Safety Specialist & ID Checker Location: Cathay Pacific Restaurant, 111 Hancock... ...Take a proactive role in helping guests avoid DUI situations by assisting with ride-share calls or ensuring they have a designated...Full timePart timeLocal areaShift workNight shiftAfternoon shiftCathay Pacific
Quincy, MA22 days ago$52.25k - $78.37k
...Associate Specialist (Animal Sciences & Technologies) Introduction to role Are you ready to make a meaningful impact on patients through science-led preclinical research support? In this role, you will provide animal care that helps enable high-quality in vivo...Full timeTemporary workWork at officeLocal area$15 - $20 per hour
...may apply if applicable criteria are met. The Delivery Specialist will maintain and operate store vehicles to deliver parts and/... ...in and putting up stock orders, etc. May occasionally assist customers, serve as a cashier, and/or help with merchandising tasks...Hourly payMinimum wageFull timeLocal areaImmediate startFlexible hoursO'Reilly Automotive Stores
Watertown, MA2 days ago- Description: Paint Specialist | Full-Time | Mattapan, MA Turn your paint expertise into a career. If you're the person customers trust to recommend the right products, match the perfect color, and solve painting challenges, we'd love to meet you. The Norfolk Companies...Hourly payFull timeFor contractorsWeekend work
The Norfolk Companies
Mattapan, MA1 day ago - QUALIFICATIONSU.S. Bachelor’s degree or equivalent work experience required4+ years of consulting, law, risk, compliance, communications, or other relevant professional services experience Demonstrated intellectual curiosity and integrity, including affinity and abiding...For contractorsApprenticeshipWork experience placementFor subcontractor
- QUALIFICATIONSBachelor's degree, advanced degree preferred5+ years of relevant experience, including experience with at least one of the following areas: Payment Integrity including Fraud, Waste & Abuse; Medical & Pharmacy Cost Optimization; Network optimization; Administration...ApprenticeshipWorldwideEasy work
$83.2k - $124.8k
...#HappyatFoley, and we think you will be too.The Business Development and Marketing Senior Specialist will interact with office leadership, attorneys, and business professionals, to assist and execute projects, programs, activities, and processes that support the business...Temporary workWork at office- ...a person who is too awesome, who loves the role and works with a lot of passion. We are awaiting to meet the excellent analytic specialist exactly like you. We would love to listen to your career success and will anticipate for your interest towards this job and I believe...
- We’re seeking a future team member for the role of Senior Specialist to join our Fund/Client Accounting team. This role is located in Boston, MA. In-office requirement is four days.In this role, you’ll make an impact in the following ways:Conducts accounting services on...Work experience placementWork at officeWorldwideFlexible hours
- ...Responsibilities:Reporting to the Manager of Award Operations, the Award Specialist independently serves as a subject matter expert and... ...caregivers Professional development opportunities including tuition assistance and reimbursement Commuter benefits, discounts and campus...Work experience placementWork at officeRemote work
- Job-ID32553304Reference26-01181Remote50% Remote Qualifications: LabWare LIMS Configuration. Configure raw materials, commercial products including stability, and laboratory equipment in LabWare LIMS using standardized, compliant design patterns. Ensure LabWare configuration...Remote work
$89.6k - $166.4k
...of site HSE facility and contractor safety programs in alignment with local, regional, and global requirements. This position will assist in management of potential risks to human health and/or the environment resulting from activities involving facility maintenance operations...Full timeFor contractorsLocal areaRelocation package$83.2k - $124.8k
...be too.Foley is currently seeking a Business Development & Marketing (BD&M) Senior Specialist to join our team! The right candidate will have strong project management skills and assist the Business Law Department in managing and executing initiatives that support the...$125k - $135k
...the Health Information Technology field?We are excited to announce that currently we are looking for Health Information Technology Specialists to support an IQVIA pharmaceutical client partnershipThis individual will have the unique opportunity to be a part of multiple...Full timePart timeImmediate startWorldwideNight shift- QUALIFICATIONSBachelor’s degree required; advanced degree is a plus (if you are less than 8 years out of undergrad, please include your GPA on your resume)TS/SCI clearanceWillingness to travel upwards of 70%Outstanding record of academic and/or professional achievementDemonstrated...ApprenticeshipWork at officeEasy work
- OverviewAccenture helps the world’s leading enterprises reinvent by building their digital core and unleashing the power of AI to create value at speed for organizations across industries. Our strategy is to be the reinvention partner of choice for our clients and lead ...Full timeLive inWork at officeLocal area
$20.76 - $31.14 per hour
...Disease Epidemiology (TIDE) group within HPHCI and Harvard Medical School’s Department of Population Medicine (DPM) ( as a Research Assistant. TIDE is the home of several large, complex, multi-institutional research initiatives based within health systems using electronic...Full timeWork at officeWork from homeFlexible hoursPoint32Health
Boston, MA4 days ago- ...provide input on experimental design Other Responsibilities Participate in lab meetings and communicate results clearly Assist with reagent preparation and inventory tracking Contribute to protocol optimization and scaling efforts Engage with safety...WorldwideVisa sponsorshipWork visa
Tessel Bio
Cambridge, MA4 hours ago $100.71k - $146.07k
...lighting, vertical transportation, commissioning, and energy modeling. We are looking for a Sustainability - Senior Sustainability Specialist to join our Boston, MA office.Your experience working in a consulting design firm working on projects such as commercial building...Work at officeLocal areaRemote workWork from homeFlexible hours- Job-ID32405843Reference26-00922Remote50% Remote Job Description: LabWare LIMS Configuration Specialist to support the LabWare 8 upgrade for a US based GMP laboratory site. This role will lead a dedicated workstream focused on implementing raw material and commercial product...Remote work
$80k - $105k
OverviewWe are seeking a hands-on, versatile Technology Specialist — a true "jack of all trades" combining end-user computing, systems administration, and network support with a forward-looking mandate: helping our scientists and G&A teams work smarter through automation...Work at officeRemote work- QUALIFICATIONSBachelor’s or master’s degree with 4+ years of experience in consulting, investment banking, private equity or corporate strategy; healthcare experience is preferredComfortable interacting with senior leadership and working across multiple groups and stakeholdersHighly...ApprenticeshipWork at officeEasy work
$90k - $110k
...team members to contribute in a larger capacity than is possible in typical positionsPosition DescriptionThe Regional Colorectal Specialist (RCS) is responsible for providing minimally invasive surgical solutions to hospitals with an immediate focus on our GelSeal® technologies...Local areaImmediate start
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Pharmacovigilance Specialist / Assistant. Be the first to apply!
Related searches
- welding specialist Boston, MA
- transportation specialist Boston, MA
- imaging specialist Boston, MA
- title specialist Boston, MA
- e learning specialist Boston, MA
- employment specialist Boston, MA
- employment placement specialist Boston, MA
- deployment specialist Boston, MA
- localization specialist Boston, MA
- order entry specialist Boston, MA