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Company

myGwork - LGBTQ+ Business Community · 7 hours ago

Pharmacovigilance Associate

Michigan, United States

Full-time

Remote

Entry Level

2+ years exp

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Responsibilities

Respond and process medical information inquiries from healthcare professional, consumers, regulators and internal colleagues, including inquiries related to adverse events/reactions and product complaints for Clients’ product(s), as per their agreement with ICON.

Triage information received based on regulatory requirements and applicable SOPs ensuring adverse events, product complaints and medical information queries are handled in a compliant manner.

Complete adverse event follow-up by phone or in writing based on requirements for each Client and/or case.

Prioritizing and complete multiple projects within established time frames.

Managing client projects; including managing client relationships and project budgets

Monitoring and managing project-specific email accounts, incoming faxes, and telephone calls. Preliminary triaging of incoming information to determine classification, priorities, and time frame for subsequent activities.

Entering information for medical information inquiries into medical information databases, tracking systems and project- specific forms ensuing accurate data entry.

Maintaining a library of responses to Frequently Asked Questions and of Standard Response Letters.

Preparation of Standard Response letters, including conducting literature search, article summary etc.

Responding to medical information inquiries within pre-determined timelines and constraints, requesting assistance from clients and safety physicians as appropriate.

Identifying individual Case Safety Reports and technical product complaints and forwarding them to relevant stakeholders within pre-determined timelines.

Assisting with or performing reconciliation of safety databases, safety tracking systems, medical information databases, product complaint database, and clinical databases.

Monitoring and interpreting worldwide regulations pertaining to medical information and pharmacovigilance, providing regulatory expertise to colleagues and clients.

Assisting with regulatory agency inspections, client audits, and internal audits.

Participating as an active member of multidisciplinary terms to successfully achieve project and corporate goals. Identifying project issues and developing proposals for alternative strategies for discussion with superiors.

Completing other appropriate duties as assigned by line manager that requires similar skills.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Medical information inquiriesPharmacovigilanceHCP DoctorHCP NurseHCP PharmacistData entryRegulatory expertiseAdditional language capabilities

Required

Strong written & oral communication skills in English

HCP (Doctor, Nurse, Pharmacist)

Bachelor's degree or equivalent experience required

2 plus years of experience

Preferred

Additional language Capabilities an asset

Benefits

Various annual leave entitlements

A range of health insurance offerings to suit you and your family’s needs.

Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.

Life assurance

Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.