Medical Information Specialist - Life Science Graduate

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world's largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.

The Medical Information Specialist (MIS) position is part of the ProPharma 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's pharmaceutical clients.
• Provides labeled and unlabeled medical / safety information responses in accordance with regulatory requirements, industry standards and client and ProPharma 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 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.

Qualified candidates must have :

LI-KP1

LI-REMOTE

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.