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Job Details

Safety Physician (Europe)

Company: INC Research
Location: Poland or UK
Reference: 17003070
Closing Date: 08 Oct 17
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life.

Requirements:

With safety concerns becoming increasingly common among doctors and patients, having robust and accurate data helps us gain the trust of our customers.

Our Safety and Pharmacovigilance service has been one of our core offerings since 1992. We have a global team of experts who can support our customers across all phases of clinical trials and post marketing surveillance ensuring timely collection, analysis and reporting of safety data according to each company’s regulations.

 

We are currently recruiting a Safety Physician to be located in any of our European locations.

 

A summary of duties you will be involved in as a Safety Physician:

 

1. Reviews all appropriate safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the product development life-cycle.

2. Conducts medical assessment of all safety related data (AEs, SAE, SUSAR, AESI etc.).

3. Ensures medical accuracy of case narratives, coding and medical sense of all cases and ensures appropriate queries are raised to expedite case closure.

4. Provides analysis of similar events (AOSE).

5. Writes safety section, including benefit risk assessment of all aggregate safety reports such as Periodic Drug Safety Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), DSUR/IND Annual reports and line listings of Suspected Unexpected Serious Adverse Reactions (SUSARs) for regulatory submission.

6. Provides product safety training to internal employees and external contractors / vendors as needed.

7. Participates in investigators’ meetings to provide training on adverse events reporting as required.

8. Prepares and may present product safety issues at meetings, both internal and external.

9. Authors/reviews relevant sections of all aggregate safety reports and ensures the overall quality of documents.

10. Assist in the creation, review and implementation of new SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety.

11. Responsible for responses to queries from regulatory authorities or health care professionals on safety issues and any legal queries and requests involving safety issues.

12. Familiar with MedDRA, WHODRL and safety databases such as ARGUS.

13. Ensure ongoing safety monitoring of investigational and marketed products to include detection of signal and assessment of risk, assessment of the risk-benefit balance of products and analysis of the overall safety of products.

14. Medical contribution to risk management activities including Risk Management Plans (RMP) and Risk Evaluation and Minimization Strategy (REMS).

15. May have line management responsibilities for physicians within the Safety & PVG department. May participate in management activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Reviews and approves time records, expense reports, requests for leave, and overtime (where appropriate).

 


 

Qualifications
 
To succeed in this role you will need the following skills/experience:


A doctoral-level degree in medicine or equivalent combination of education and experience.

Clinical experience in the practice of medicine.

Experience in a Clinical Research Organization and related therapeutic specialities preferred.

Strong understanding of the use of medical terminology and of drug-names in multiple nations and environments.

Proficient with Microsoft Office Suite (Word, Excel), databases, email, internet, and smart phones.

Excellent verbal and written communication skills (proficient in English) as well as strong presentation skills.

Ability to multitask under tight deadlines while providing attention to detail and high quality work in a dynamic environment.

Ability to be flexible, adapt to change, work independently, as well as experience working in a matrix environment.

Ability to be customer-focused and have a disciplined approach to work.


What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.

Apply for this job: Safety Physician (Europe)

Contact Information:

Address:  INC Research Europe
Királyhágó tér 8-9, 2th floor, 1126 Budapest, Hungary
1126
Hungary
Tel:  +36 1 489 48 56
Website:  Visit Our Web Site

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