ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Groups fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in todays dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
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:
1. Fully functional member of the Medical Information Contact Center.
2. 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 Groups pharmaceutical clients.
3. Provides labeled and unlabeled medical/safety information responses in accordance with regulatory requirements, industry standards and client and ProPharma Group internal policies and practices.
4. 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 SOPs and client working practices/instructions.
5. 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.
6. Performs follow-up with inquirers at request of client.
7. Participates in project lead/client activities as appropriate.
8. Assists and/or performs literature evaluations including Periodic Safety Updates, Literature Summaries and other medical writing projects as needed.
9. Assists in providing training support to department new hires.
10. Assists Medical Information Coordinator in providing full and compliant documentation per SOPs.
11. Provides after-hours coverage on a rotated basis.
12. Adheres to company and country-specific privacy policies.
13. Other activities as assigned.
- Nursing Degree (RN/BS/BA/MS) required.
- Minimum: 1 to 3 years of healthcare practice.
- Preferred: 1 to 3 years of experience in a drug information setting (including fellowship programs) or in the pharmaceutical industry.
- Multilingual in French and English is required.
- Working knowledge of medical terminology, pathophysiology, pharmacology, regulations and industry standards.
- Strong cognitive abilities, including verbal reasoning, critical thinking and analytical ability.
- Ability to correctly identify inquirers question(s) and formulate and communicate an accurate response utilizing multiple resources for information which may require scientific interpretation.
- Excellent interpersonal skills including empathetic customer service skills.
- Ability to multitask with attention to detail within restrictive timeframes.
- Proactive with demonstrative ability to independently identify problems and suggest effective solutions.
- Ability to organize and prioritize in quickly changing environment within resource constraints.
- Ability to learn, take instruction and apply to daily operations/tasks.
- Receptive to constructive feedback.
- Self-motivating. Ability to demonstrate initiative and internal drive. Willingness to seek out additional workload projects.
- Effectively work independently and as part of a team.
- Highly proficient in computer applications, including Microsoft Office software platforms and Adobe Acrobat, and experience using a document management system. Aptitude to learn other computer systems including inquiry handling database.
All candidates must be legally eligible to work in the Canada.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***