Drug Safety Physician (Remote)

Drug Safety Physician (Remote)
Empresa:

Beacon Hill Pharma


Drug Safety Physician (Remote)

Detalles de la oferta

Job Description

* Participate in or lead safety management teams for clinical programs.
* Serve as the safety point of contact to other colleagues (RA, QA, Medical Affairs)
* Create regulatory reports and analytical papers, gathering and categorizing data, providing initial medical analysis and/or overall benefit/risk.
* Create, or assist in creating:
1. PBRERs, DSURs, PADERs
2. Signal detection activities
3. Create and/or review safety portions of submission documents
* Ability to participate in bridging communications between business and safety to ensure appropriate safety context is conveyed.

Requirements:
* Physician with relevant, hands on safety experience.
* At least 3 years of hands on PV experience in clinical and/or post marketing
* Solid understanding of regulations impacting Pharma industry in the US and globally, especially drug safety/ PV
* Hands on experience writing/reviewing Aggregate Reports , e.g., PBRERs, DSURs, and PADERs
* Hands on experience with signal detection activities such as
analyzing/categorizing/
assessing data
* Strong leadership skills
* Excellent oral and written communication skills
* Excellent listening and comprehension skills
* Ability to work effectively in a matrix setting to resolve issues and achieve common goals
Company Description
Beacon Hill Pharma, Beacon Hill Staffing Groups Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations.

Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting and Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.

Whether start:ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.:ul


Fuente: Tiptopjob_Xml


Área:

  • Other Jobs / Other Jobs - Crafts

Requisitos

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