Job Description
The Medical Information Specialist (MIS) position is part of the ProPharma Group Medical Information Contact Center and follows all corresponding regulations, industry standards, and client/internal policies regarding medical information and the collection and documentation of adverse events, special situation events, and product complaints.
Essential Functions Include:
- Fully functional member of the Medical Information Contact Center.
- Responds to unsolicited consumer, health care professional and other external customer requests for medical and safety information received via the contact center, website/e-mail and scientific meetings on behalf of ProPharma Group’s pharmaceutical clients.
- Provides labeled and unlabeled medical/safety information responses in accordance with regulatory requirements, industry standards and client and ProPharma Group internal policies and practices.
- Accurately identifies, documents and reports adverse events, pregnancy reports, special situation events and product complaints in a clear and concise manner within required timeframes per government regulations, ProPharma Group Standard Operating Procedures (SOPs) and client working practices/instructions.
- Formulates and provides accurate responses utilizing approved labeling and company standard responses, published literature and other data (e.g. internal clinical data, post-marketing surveillance data). Assists with writing custom responses utilizing this data.
- Performs follow-up with inquirers at request of client.
- Participates in project lead/client activities as appropriate.
- Assists and/or performs literature evaluations including Periodic Safety Updates, Literature Summaries and other medical writing projects as needed.
- Assists in providing training support to department new hires.
- Assists Medical Information Coordinator in providing full and compliant documentation per SOPs.
- Provides after-hours coverage on a rotated basis.
- Adheres to company and country-specific privacy policies.
- Other activities as assigned.