Pharmacovigilance Senior Case Evaluator

Other jobs >> General

Negotiable

Permanent

Description

Bayer is a global enterprise with core competencies in the Life Science fields

of health care and agriculture. Its products and services are designed to

benefit people and improve their quality of life. At Bayer you have the

opportunity to be part of a culture where we value the passion of our employees

to innovate and give them the power to change.



Pharmacovigilance Senior Case Evaluator



Your_Tasks_And_Responsibilities



The primary responsibilities of this role, Pharmacovigilance Senior Case

Evaluator, are to:

* Diligent evaluation and assessment of complex reports from clinical

development projects as well as post marketing cases;

* Report sources including medical literature as well as, clinical trials

and post-marketing surveillance studies;

* Ensure high medical quality and compliance with all health authority

requirements regarding adverse event / adverse drug reaction (AE/ADR)

single case handling;

* Ensure medical plausibility, consistency and completeness of ADR case

reports;

* Request follow-up information and initiate use of specific product/event-

related questionnaires when necessary;

* Confirm determination of seriousness, assess drug product causal

association and global labeling status (expected or unexpected) in order

to achieve the appropriate case reporting status for global distribution

for regulatory agency reporting;

* Provide medical/clinical advice for non-medic group members and medical

coding of various case data including all AE and Drug terms which require

in depth knowledge of the present coding systems (MedDRA and WHO-DD) with

respect to structure and medical content;

* Create written company causality comment for ADR case reports in

accordance with internal standards and guidelines, including specific

aggregate analyses and summary description of previous similar reports

when required;

* Identify critical case reports that require immediate attention of the

Global Safety Leader (GSL), including cases that are potentially suitable

for extended discussion in PV aggregate reports (PBRER/ PSURs, DSUR and

ASRs);

* Serve as mentor for pharmacovigilance (PV) Case Processors;

* Participate in AE/SAE reporting compliance analysis when necessary;

* Contribute to a continuous improvement of PV system and processes;

* Prepare and conduct trainings on case processing topics of interest.

*



Who_You_Are



Your success will be driven by your demonstration of our LIFE values. More

specifically related to this position, Bayer seeks an incumbent who possesses

the following:



Required_Qualifications

* MD degree (preferably with 2 or more years of clinical experience); OR

aPhD, PharmD, DPM, or DVM degree, MS, BS RPH, RN HCP or Life Science

degree plus a minimum of 3 years of pharmacovigilance experience;

* Possess good medical/clinical interpretation skills based on potentially

limited information provided along with a comprehensive understanding of

medical terminology and proven capabilities in differential diagnosis;

* Possess basic knowledge of International Council for Harmonisation (ICH)

principles of SAE/AE reporting along with basic understanding of local

and global regulatory rules and regulations and basic knowledge of safety

policies and procedures in the major countries;

* Possess good understanding of AE and drug coding conventions (MedDRA,

WHO-DD);

* Basic knowledge of standard office software packages (Word, Excel);

* Excellent oral and written communication skills;

* Fluency in English (verbally and in writing) and be able to fluently

communicate with colleagues from PV data entry sites in other countries;

* High sense of responsibility and accountability and special sense for

diligence even for routine processes;

* Proactive behavior and ability to keep timelines;

* Possess well established interpersonal, decision-making and

organizational skills, along with practiced training skills;

* Be able to identify problems in case evaluation and to assist in the

design workable solutions;

* Possess or quickly develop the ability to establish cooperative working

relationships with staff from different cultural and medical backgrounds;

* Drive results and manage complexity.

*



Preferred_Qualifications

* MD with at least 2 years of clinical experience.

*



Relocation assistance offered.



YOUR APPLICATION



Bayer offers a wide variety of competitive compensation and benefits programs.

If you meet the requirements of this unique opportunity, and you have the

"Passion to Innovate" and the "Power to Change", we encourage you to apply now.

To all recruitment agencies: Bayer does not accept unsolicited third party

resumes.



Bayer is an Equal Opportunity Employer/Disabled/Veterans



Bayer is committed to providing access and reasonable accommodations in its

application process for individuals with disabilities and encourages applicants

with disabilities to request any needed accommodation(s) using the contact

information below.



Location:



United States : New Jersey : Morristown



Division



Pharmaceuticals



Reference_Code







Contact Us



1 , option #5

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  • Negotiable
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  • Re-125357
  • Permanent
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