Pharmacovigilance Lead

Key People

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Job ID :

15143


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

Western Europe,--Paris,Paris,


Key Skills :

Phamacovigilance, PV, drug safety, management, manager, lead, leader


Salary :

Negotiable


Date Posted :

24 Jul, 2019



Company Name :

Key People


Location1 :

Paris




Job Category :

Pharma Research & Development Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

Responsibilities include:

* Serves as the expert on all aspects of ICSR management activities and makes decisions in accordance with global regulations, guidelines and industry best practices
* Manages and oversees members of the Pharmacovigilance Team
* Ensures all ICSR management activities comply with national regulatory requirements, corporate and internal procedures and applicable Pharmacovigilance (PV) agreements
o Ensures all ICSRs received by the company are tracked, data entered, processed and submitted or notified, in an accurate, complete and timely manner as per company procedures and clinical study protocols
o Determines regulatory reporting pre-assessment and prioritization as per company procedures
o Confirms accuracy of ICSR information reported and collected and requests additional information from Reporters, when applicable
o Prepares regulatory submissions and notification packages (I.e. CIOMS/MedWatch, Dear Dr/Investigator/EC letters) to be distributed to Regulatory Affairs and Clinical Development
* Provides appropriate representation during regulatory inspections, internal audits and partner audits; collaborates cross-functionally as well as internally with the DS&PV team, Regulatory Affairs and Clinical Development staff
* Contributes with Compliance and Training (CAT) in the development and implementation of department policies, procedures, standards, rules and conventions, and participates in safety-related educational programs for internal and external customers
* Establishes on a monthly basis an activity and compliance report (i.e. number of cases per study, cases of AESI, SUSARs, CU)
* Accountable for the reconciliation of cases received from clinical study investigators on a monthly basis


Skills and qualification:

* Health Care Professional degree (e.g. RN/BSN/MSN, NP, PA, RPh/ PharmD/ B.Pharm or MD)
* Minimum 4 to 5 years of clinical or Safety related experience (Preferred)
* Writing experience; science/medical writing (Preferred)
* Computer proficiency (Required)
* Demonstrates capability to comprehend medical information
* Works effectively, independently and collaboratively
* Strong organizational skills, detail oriented and adapts in a fast paced, changing environment
* Demonstrates ownership, initiative and accountability
* Excellent communication skills, both written and verbal
* Ability to prioritize tasks in a timely manner
* Ability to interact effectively in a multifunctional, multidisciplinary team setting


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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