Medical Reviewer with PV experience (Prague, Czech Republic)

We solve our clients' toughest challenges by providing unmatched services in
strategy, consulting, digital, technology and operations. We partner with more
than three-quarters of the Fortune Global 500, driving innovation to improve the
way the world works and lives. With expertise across more than 40 industries and
all business functions, we deliver transformational outcomes for a demanding new
digital world.

Accenture Operations combines technology that digitizes and automates business
processes, unlocks actionable insights, and delivers everything-as-a-service
with our team's deep industry, functional and technical expertise. So you can
confidently chart your course to consuming your core business services on
demand, accelerate innovation and speed to market. Welcome to the "as-a-service"
business revolution.

JOB SPECIFICATION:
Join an interesting project supporting an international pharmaceutical company
by performing timely data processing in the safety database for received source
documents of cases collected during safety monitoring of drugs and compounds.

In this position you would be responsible for medical review and assessment of
Adverse Events within agreed timeframes and to a high standard of accuracy, in
compliance with Customer business rules, standard operating procedures and
global regulatory requirements as documented in Customer’s SOPs.

Additionally, the Medical Reviewer ensures integrity and consistency of data
against source document by performing QC and appropriate correction of all
processed cases in appropriate timelines as per standard operation procedures.

RESPONSIBILITIES:

* Review and verify appropriate selection of adverse events from source
documents, assign appropriate MedDRA code, assess labeling, review narrative and
provide company comment in accordance with client requirements
* Acquire and maintain current knowledge of product portfolio and safety
profiles of for products across therapeutic areas
* Identify, escalate and resolve case issues, co-ordinate with client
therapeutic team/site for specific products or functional groups
* Communicate and interact effectively
* Follow up with sites regarding outstanding queries
* Follow up on reconciliation of discrepancies
* Perform other drug safety related activities as assigned

REQUIREMENTS:

* EU Medical Degree Required (e.g. MUDr., MBBS, M.D.)
* Minimum 1-3 years of clinical experience
* High degree of accuracy and attention to detail
* Experience and skills in working on computers
* European trained and certified physician with min 24 months clinical practice
* Clinical experience in oncology/hematology would be an asset
* Experience of ICSR management in a PV database (min 12 months), incl. triage,
data processing, quality check, medical assessment and follow-ups
* Experience in MedDRA coding execution (LLT, PT, SOC, SMQs)
* GVP modules - Especially module VI (Management and reporting of adverse
reactions to medicinal products)
* An overview of PV in post-marketing & clinical trials settings (assessment of
Listedeness/expectedness against of IB/CCDS
* Fluency in oral and written English

WE OFFER:

* Position in the world’s leading global company
* Professional growth based on performance
* Continuous training
* Wide range of benefits – 5 weeks of holiday, meal vouchers,
recreation/wellness vouchers, pension/life insurance etc.

HOW TO APPLY:
If you are interested in working with us please send us your resume to email
address [email protected]

By providing us your personal data in your CV, you have allowed Accenture to
process and file your CV in the HR database. Your personal data will be used for
the internal HR needs of Accenture only.

At the same time you confirm herewith that the personal data as stated in the CV
you have sent to us is true and accurate.

INFORMATION ABOUT THE VACANCY
JOB LOCATION
Bucharova 1314/8, 158 00  Praha-Stodůlky, Czech Republic

EMPLOYMENT TYPE
Full-time work

TYPE OF EMPLOYMENT
Employment contract

DURATION OF EMPLOYMENT
Permanent

BENEFITS
Notebook, contributions to the pension / life insurance, flexible start/end of
working hours, meal tickets / catering allowance, holidays 5 weeks, educational
courses, training, cafeteria, sick day

REQUIRED EDUCATION
University

REQUIRED LANGUAGES
English (advanced)