Safety (PV) Physician at Beacon Hill Staffing Group, LLC in Baton Rouge, Louisiana

Job Description:

Beacon Hill Life Sciences is actively recruiting for a Safety/ Pharmacovigilance (PV) Physician (MD) to work a contract (to potential hire) assignment.

• This assignment will begin part-time (20 hours).


• Duration: 3-6 months to start, potential contract to hire. (If hired after contract period, poisiton would move to full-time therefore must be able to work part-time now with flexibility for full-time work later.)


• Location: Remote


• Pay Rate: Based on experience, range $200 - $230/hour.


• Assignment is open due to growing team and growth within company.

In order to be considered, candidate must have the following:

• 
  MD degree
  


• 
  10+ years of experience in drug development and in drug safety/pharmacovigilance required.
  


• 
  Gene Therapy experience
  

This assignment is for a Physician Safety Leader with broad experience in drug development and drug safety from biotech and/or pharmaceuticals. If you are a strong problem solver, agile with regulations and requirements for global safety surveillance & safety risk management in drug development and post-marketing settings, and enjoy cross-functional partnerships, this is the role for you!


You are to lead and work in a fast paced, growing drug safety & pharmacovigilance department and contribute to establish a state-of-the-art safety surveillance program for novel gene-editing therapies.


You will be on a product/program team and will need to work collectively with all DSPV team members including medical, clinical operations, data management, biometrics, regulatory, quality and manufacturing.



Responsibilities include:

• Develop strategy for Safety surveillance for the clinical trials across platform in collaboration with clinical development team


• Manage safety signals and lead cross-functional safety management team


• Lead DSPV in various cross-functional teams (e.g., Clinical program teams)


• Lead cross-functional project on developing guidance for long-term safety assessment of gene- editing products


• Perform medical review of SAEs, SUSARs and aggregate safety data from all sources in collaboration with CRO medical monitors


• Lead the development of safety risk management plans, IND annual safety reports


• Develop and update RSIs for IBs


• Develop and contribute for IND/BLA safety deliverables and regulatory responses


• Develop and contribute for safety surveillance SOPs, participate in PV audit and inspections


• Collaborate with PV Operation on DSPV functional deliverables


• Supervise, coach and mentor safety/risk management scientists

Requirements:

• Medical Degree (MD) required.


• Solid clinical experience from direct patient care (clinical experience and/or board certification in Oncology, Immunology, Genetics desired) and 10+ years of experience in drug development and in drug safety/pharmacovigilance required.


• Knowledge and hands-on experience of the good pharmacovigilance practices and international regulatory requirements such as EMA/FDA/ICH guidelines required. Prior experience in leading and authoring safety guidance documents, position papers, safety sections of IND or BLA submission dossiers required.


• Have a curious mindset for the new challenges to pharmacovigilance that accompanies novel gene editing therapies. Experience with gene therapy products required.

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.


If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/


Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.

Company Profile:


Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.


Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.


Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.beaconhillstaffing.com .

We look forward to working with you!


Beacon Hill. Employing the Future™
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