As a result of continued demand for our products and services, Mapi is adding a Pharmacovigilance Operations Specialist I to our team! This position will be based onsite in Lexington, KY. Relocation assistance is not available.
The Pharmacovigilance Operations Specialist I is responsible for the receipt, processing, reporting, quality control, submission and management of Individual Case Safety Reports (ICSRs) in compliance with applicable regulations, SOPs and project specific operational agreements.
Your Responsibilities and Accountabilities:
- Monitoring and managing project specific email accounts, incoming faxes and telephone calls. Preliminary triaging of ICSRs to determine classification, priorities and time frames for subsequent activities.
- Enter source information for ICSRs to safety databases, tracking systems and/or project specific report forms ensuring accurate data entry
- Performing preliminary coding of ICSRs using MedDRA, WHODrug and database-specific dictionaries.
- Preparing draft narratives for ICSRs.
- Submitting ICSRs to regulatory agencies, clients or client partners in accordance with predetermined documented distribution rules.
- Responding to logistics enquiries from investigators and site staff participating in Mapi studies.
- Preparing ICSR files for the purposes of third party review including adjudication, review by Drug Safety Monitoring Boards, etc.
- Build and maintain positive and productive liaison with internal and external contacts.
- Effectively prioritize and complete multiple projects within established time frames.
- Identify client issues and develop alternative strategies for consultation with other managers.
- Participate in and support project teams and advise other departments on regulatory issues and strategies.
- Participate and assist in preparations for regulatory inspection/internal audits.
- Other duties as assigned.
- 4 year degree or equivalent experience
- Sound written and verbal communication skills
- Direct experience and working knowledge of adverse event reporting
- Ability to build positive, productive relationships with colleagues and clients
- Strong computer skills and training in current software applications (MS Office, MS Excel)
- Demonstrates organizational, planning and problem solving skills
- Travel less than 10% annually
- Displays full knowledge of protocol, regulatory requirements, and company SOPs.
- Identifies, documents, and discusses protocol violations, regulatory non-compliance, and issues involving subject safety.
- Distinguishes between good practice and regulatory requirements.
- Applies knowledge into practice on-site.
#Rightjob – What will you get?
Mapi is a leading global organization, offering evaluation and support of therapeutic strategies. We are committed to improving the quality of patient care worldwide by offering innovative and insightful solutions for successful market access to people who are shaping tomorrow’s health care whilst always ensuring the voice of the patient remains at the heart of what we do.
With offices worldwide, Mapi provides high quality and efficient operations to help our clients secure product approvals and reimbursement, as well as addressing post- marketing requirements and late phase needs, meeting the needs of patients, physicians, regulatory authorities and health care technology purchasers.
At Mapi, we embrace our values, and everyone that works here is expected to demonstrate these values and associated behaviours in their day-to-day work. Our values are the foundation of the work we do, and include ownership, transparency, fairness, adhere to beliefs, adaptation, empathy and sincerity….to name but a few.
We provide a dynamic, stimulating and rewarding working environment for ambitious and passionate individuals looking to join a world-class consultancy business. Not only will you be supported through coaching, leadership, mentor programs and formal training to ensure you have the opportunities for continuous professional development, we recognize the need to ensure your personal life balance needs are also met.
We are an EEO Employer in all locations, and are compliant with the US EEOC.