Covance Drug Safety Physician in Sofia, Bulgaria

Job Overview

Covance is looking to recruit Drug Safety Physician in Poland or Bulgaria - full time permanent, office or home based role.

Therapeutic And Scientific Expertise

Responsible for medical review of serious adverse events and nonserious adverse events from spontaneous reports and reports derived from regulatory authorities and the medical literature during postmarketing surveillance in support of drug safety activities for clients.

Assumes responsibility for medical and safety monitoring on assigned projects

When applicable, responsible for preparation and medical review of Aggregate Reports (Periodic Safety Update Reports – PSURs, Periodic Adverse Drug Experience Reports – PADERs) required by global regulatory agencies for review of safety information for assigned products, when authorized to perform this function on behalf of a client.

Participates in training opportunities to advance knowledge of pharmacovigilance as it relates to drug/product development and drug/product marketing utilizing good clinical practice guidelines

Provides medical/safety expertise to project teams, including communicating information regarding drug safety regulations and any changes that have occurred

Provides pharmacovigilance support to project physicians, as appropriate

Reviews laboratory values, adverse events, coding dictionaries and data tables, listings and figures as needed to identify drug safety issues in collaboration with the project physician

Assists in the preparation of pharmacovigilance materials for investigator meetings

Participates in project risk assessment activities

When applicable, responsible for signal detection and evaluation activities and preparation and submission of Ad Hoc Reports reviewing specific safety issues to the global regulatory agencies for assigned products, when authorized to perform this function on behalf of a client.

Managerial Responsibilities

Ensures adequate coverage of all project related duties

Responsible for communicating status of projects and other activities to the Senior Medical Director (Lead) and others as appropriate.

Provides mentoring to and responsible for supervision of Associate Medical Directors and Senior Managers, and mentoring to and indirect supervision of Senior Drug Safety Associates, and Drug Safety Associates

Involved in identification, interviewing and selection of candidates for Associate Medical Director and other staff positions such as DSPMs, Managers and Director of Operations as applicable

Business Development Activities

Develops new, and enhances existing, client relationships whenever possible

Presents pharmacovigilance capabilities to clients as a participant of a proposal team, when appropriate

Supports Company’s visibility and position within the contract research organization environment through publications and presentations at national or international meetings

Education / Qualifications

Required:

MD or DO with at least one year of postgraduate training or equivalent.

Preferred:

MD who has completed an accredited residency program or equivalent and is board-eligible or certified with at least 4 years experience with substantial knowledge of drug safety and the global regulations governing pharmacovigilance and risk management

Experience

  • Substantial knowledge of pharmacovigilance and the global regulations governing drug/biologics/device safety activities both during clinical development and during the postmarketing phase of lifecycle management.

  • At least 3 years of experience in pharmacovigilance & drug safety working either for a pharmaceutical company, health authority or a contract research organization

Job Number 2018-20036

Job Category Physicians

Position Type Full-Time

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