Medical Reviewer - Munich, Deutschland - Daiichi-Sankyo Europe

Daiichi-Sankyo Europe

Geprüftes Unternehmen

Munich, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Passion for Innovation

Compassion for Patients:

Medical Reviewer (M/F/x):

Purpose of the function:

Performs medical review of ICSRs supervising the global vendor and also supports other sub-functions of the Centers of Excellence (e.g. Risk Management, Signal Detection). The position serves as regional Medical Reviewer working within a global team (e.g. US, Japan) with solid medical knowledge in both oncology and specialty medicines therapeutic area. Active participation in daily medical review activities.

Serves as primary contact among DSE CSPV for medical review activities, and contributes to signal detection and safety monitoring activities.

The position works with the respective DSE product safety leads, the medical review teams from other sites (DSJ, DSI) for global alignment and DSE PV Operations team to achieve proactive and continuous improvement.

The position reports to the Medical Safety Centre of Excellence Lead DSE.

Responsibilities:

Performs medical review activities for all DSE products supervising the medical review of the global vendor
Performs checks of narratives, including medical evaluation and company comment, and checks of labelling and causality assessment as well as MedDRA coding or reported events and seriousness
Reviews and evaluates pharmaceutical technical complaints on a regular basis to identify any potential ICSRs.
Evaluates productspecific literature to identify ICSRs
Supports Centers of Excellence with medical input for Risk Management Plans, and additional risk minimization measures (e.g. educational material).

Professional experience and personal skills:

University degree and minimum 2 years of working experience
Skills to organize, coordinate and execute on details, while keeping the big picture in sight
Problem solver with the initiative to think critically to proactively identify improvement opportunities
Reliability and demonstrated ability to work in teams, as well as autonomous/without constant monitoring
Excellent written and verbal communication skills in English, additional languages are an advantage
Must be flexible in response to changing priorities due to various time zones (US & Japan)
Strong working knowledge of Microsoft Office

What we offer:

Working at Daiichi Sankyo:

At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients' needs.

We know that our bold ambition to change patients' lives for the better can only be achieved through the power of collaboration and the exploration of new approaches.

Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow.

When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.