Pharmacovigilance Lead

France, Paris, Île-de-France
24 Jul 2019
23 Aug 2019
Daniel Thorp
Clinical Research
Full Time
Contract Type
Experience Level
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