MI and Research Projects Specialist

ROLE PURPOSE

• Medical Information (MI) is a customer-focused group within Medical Department that is responsible for responding to unsolicited inquiries regarding Pfizer human prescription products and devices. Expectations related to this role include, but are not limited to, providing technical and medical information with high quality customer service. In addition the Medical Information Specialist (MIS) will be responsible for preparing responses for medical inquiries.
• Acts as a local SME (Subject Matter Expert) on Research Projects, including but not limited to IMG (Independent Medical Grants), NIS (Non-Interventional Studies).

KEY ACCOUNTABILITIES

Medical Information

• Handle inquiries received by Pfizer Romania MI from consumers and health care professionals.
• Document the inquiries and corresponding responses accurately and completely according to relevant procedures and regulatory guidelines.
• Responsible for identifying, recording and reporting adverse events and product complaints.
• Handle daily and monthly reconciliations with the Drug Safety and the Product Quality Unit.
• Responsible for researching the appropriate sources of standard response documents, medical literature etc. in line with the specificity of the MI inquiry.
• Construct response package proposals.
• Maintain a reduced period of time needed to respond to medical information inquiries.
• Maintain local medically and scientifically accurate MI documents.
• Ensures the alignment of response documents developed  by the Medical Affairs to local labeling. 
• Create and maintain or update the local MI work instructions in accordance with regional and global MI work instructions, as well as local regulations.
• Maintain a constant collaboration with field force colleagues in order to ensure an effective MI workflow.
• Maintain a constant collaboration with above country MI structures in order to ensure an effective alignment between MI Romania and EMEA and global MI.
• Work together with the legal department and the relevant medical colleagues to constantly improve all MI procedures impacted by local regulations.
• Actively participate in all MI related audits and inspections and collaborate with the relevant colleagues to ensure an outcome with no critical findings.
• Participate, if needed, in all MI regional/global meetings as the MI Romania representative and ensure an effective collaboration and alignment with other MI structures.
• Participate, if needed, in local / regional BU events and, in cases where available, handle MI intake process at a MI booth.
• Inform relevant medical colleagues regarding publication / literature updates.
• Inform relevant medical colleagues of MI KPIs.
• Delivers MI training session as part of the Pfizer Romania induction program.
• Delivers MI presentations for impcted colleagues.
• Maintain accurate technical information in MI systems.
• Maintain compliance with corporate and departmental trainings, policies and SOPs (standard operating procedures).

Research projects

• Acts as Independent Medical Grants (IMG) Administrator (primary point of contact) for Pfizer Romania
• Ensures technical  and documentation guidance for local IMGs.
• Acts as research projects point of contact for Pfizer Romania: system maintenance, administrative tasks, vendor oversight, project management.
• In collaboration with the relevant colleagues, ensures compliance with the process steps in planning, development and implementation of research projects, according to the SOP requirements as well as the external regulations.
• Actively participate in all research projects related audits and inspections and collaborate with the relevant colleagues to ensure an outcome with no critical findings.
• Ensures guidance for all colleagues involved in research projects.
• Performs protocol review, SAP review, (CRF) Case Record Form review, agreements review.
• Manages FCPA Projects and Vendors creation.
• Performs financial documents review.
• Participates in the organization of Investigator Meetings.
• Active participation in Investigator Meetings.
• Ensures vendor oversight through regular CRO (contract research organization) meetings.

REQUIRED ABILITIES

• Digital proficiency (Windows/iOS, software applications e.g. Microsoft Office, including MS Teams etc.)
• Excellent verbal and written communication skills.
• Ability to interpret and relay technical information.
• Excellent time management.
• Medical writing experience is considered an advantage.
• Demonstrates effective relationship management and customer orientation.
• Demonstrates strong oraland written communication skills.
• Demonstrates keen analytical skills and attention to detail.
• Able to work in a fast-paced environment with competing priorities.
• Ability to work independently as well as part of a team.

ROLE REQUIREMENTS

Studies: Bachelor’s degree in a science/health-related field (Pharmacy Degree Preferred).

Language competencies: High level of proficiency in both Romanian and English (written and spoken).

Professional experience: Pharmaceutical Industry experience preferred.

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Work Location Assignment: Flexible

Purpose - Breakthroughs that change patients' lives...

At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. 

Pfizer colleagues in different countries work together to improve the health of people all over the world. We are constantly working on the development of innovative therapies and growth opportunities, being in continuous search of new talents. 

Flexible Work Environment 

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation! 

Equal Employment Opportunity  

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees. 

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