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Associate Manager, PV & Drug Safety, Bulgaria

Covance 1/25/2019 1:50:58 PM
JOB ID: 27352 Category: Drug Safety Pharmacovigilance
Sofia, Bulgaria

   

 

Job Overview

As an Associate Manager, PV & DSS, you would be responsible for:

* Line-management of individuals within team as wellas a project team.
* Manage direct reports to ensure staff training records are up to date.
* Managing performance reviews and issues of direct reports.
* May manage individuals across multiple teams and will take on responsibility for cross department projects.
* Responsible for office management (schedules, desk assignments, business continuity planning, disaster recovery, etc.).
* May lead or assist with the management of PV&DSS concerning project allocation and resourcing.
* General oversight for the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to, oversight of the following types of tasks:
* Entry of safety data onto adverse event tracking systems
* review of adverse events for completeness, accuracy and appropriateness for expedited reporting;
* write patient narratives;
* code adverse events accurately using MedDRA;
* determine expectedness/listedness against appropriate label;
* identifies clinically significant information missing from initial reports and ensures its collection;
* ensure cases receive appropriate medical review;
* prepare follow-up correspondence consulting with the medical staff accordingly;
* ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines;
* reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines;
* file maintenance;

* General oversight for the management and processing of expeditable safety reports (ESRs). This includes, but is not limited to, oversight of the following types of tasks:
* review and update adverse event databases and tracking systems;
* review of adverse events for completeness, accuracy and appropriateness for ESR;
* review of patient narratives;
* review the coding of adverse events;
* review of reporting of ESRs and endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines;
* file maintenance;

* Maintain awareness of Covance's safety database conventions and system functionality.
* Maintain awareness of other client safety database conventions and functionality.
* May prepare, but definitely provide oversight to the timely preparation of pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSR) of Serious Adverse Events (SAEs) and aggregate reporting.
* Provide oversight and management of EudraVigilance activities for assigned projects.
* Contribute to the generation and review of Time and Cost Estimates for PV&DSS business.
* Support the appropriate Clinical Data Management (CDM) team(s) in the reconciliation of SAEs across safety and trials databases.
* Prepare and participate in audits, either by the client or a regulatory agency.
* Consistently contributes to solving technical and/or operational problems identified by program/project members.
* Consistently proposes and executes innovative solutions which influence program/project direction.
* Generation of monthly status, staff member performance and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
* Effectively draft/modify and deliver safety presentations:
* Client capabilities meetings, as appropriate
* "Department Overview" to internal clients

* Attend client meetings and liaise with clients where appropriate.
* Ensure compliant safety reporting in accordance with international reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team.
* Responsible for cascading relevant information from internal and external meetings to direct reports and appropriate colleagues.
* Train new employees overall in pharamcovigilance and regulatory reporting.
* Maintain a comprehensive understanding of Covance PV&DSS' SOPs, Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
* Possess knowledge of all other CDS procedural documents that impact PV&DSS.
* Assist with the generation and review of SOPs, Work Instructions etc.
* Responsible for SOP implementation within assigned team.
* Assist in developing Operational metrics measuring PV&DSS' overall performance.
* Assist with the recruitment of new staff to PV&DSS.
* Build and maintain good PV&DSS relationships across functional units.
* Demonstrate role specific Competencies on consistent basis.
* Demonstrate company Values on consistent basis.
* Financial authority as it relates to personnel and projects.
* Any other duties as assigned by management.

Education / Qualifications

Level of education required (or Experience level which may be substituted for level of education).

Professional designations/certifications/licenses required:

* Non-degree + 6-7 yrs safety Experience * including 2 years of team leadership Experience ***
* Associate degree + 5-6 yrs safety Experience * including 2 years of team leadership Experience
* Associate degree RN + 5-6 yrs safety Experience * including 2 years of team leadership Experience
* BS/BA + 4-5 yrs relevant Experience * including 1-2 years of team leadership Experience
* MS/MA + 3-4 yrs relevant Experience ** (2-3 yrs safety Experience ) including 1-2 years of team leadership Experience
* PhD / PharmD + 2-3 yrs relevant Experience ** (1-2 yrs safety Experience ) including 0-2 years of team leadership Experience

For PharmD, a one year residency of fellowship can be considered relevant Experience .

Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.

*Safety Experience includes actual Experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and Experience with regulatory submissions.

**Relevant Experience includes Experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.

***Team leadership Experience includes Experience bearing overall responsibility for work products generated for customers by supporting team members operating in matrix environment, assigning and coordinating work executed by a team of supporting staff, organizing efforts of more than one individual to achieve common team objectives.

EudraVigilance Certification preferred

Experience

* Strong relationship-building and interpersonal skills.
* Good ability to assess staff performance and propose effective strategies to enhance existing strengths and fill any noted skill or knowledge gaps.
* Good ability to propose solutions to effectively address any performance issues.
* Ability to provide mentorship and guidance to project support staff.
* Ability to grow and develop project support staff through multiple levels within the department career ladder.
* Ability to coach project support staff in development of technical skills, efficiency and quality.
* Ability to work independently in a staff management capacity, in regular consultation with management.
* Ability to perform project review and process analysis, identify potential risks and process improvements – and propose appropriate action.
* Functions as a positive, engaging and motivating team player.
* Ability to direct, manage and coordinate the day-to-day efforts of multiple levels of staff.
* Ability to effectively balance multiple concurrent priorities in a fast-paced, complex setting.
* Ability to effectively manage multiple internal and external customers competing concurrently for attention, services and resources.
* Good verbal, written and presentation skills.
* Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level.
* Work collaboratively with PV&DSS Management's team
* Leadership capabilities
* Good Communication
* High degree of accuracy with attention to detail.
* Ensure client and global regulatory compliance.
* Will present and share useful business information across departments and functions
* Anticipate/identify problems and takes appropriate action to correct.
* Knowledge of medical and drug terminology
* Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
* Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products
* Knowledge of Medical Device Reporting desirable
* Knowledge of aggregate reporting desirable
* Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
* Financially intuitive
* Knowledge of ICH guidelines.
* Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.


Position Type: Full-Time

Location: Sofia, BGR - Bulgaria



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Hiring team members will share and discuss their input and then make their decision.

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