Medical Director Pharmacovigilance

Company: Spectraforce Technologies Inc
Location: Cambridge
Posted on: September 14, 2020

Job Description:

SPECTRAFORCE is an award winning global staffing, IT services and consulting company that specializes in providing top talent and solutions for clients throughout North America and India. We pride ourselves on our partnership with our clients, MSP/VMS providers, and our employees, who have enabled us to continually be ranked as a Top Supplier in the 75+ different clients we support. Medical Director Pharmacovigilance

08-19-2020

Cambridge, MA

246989

What we do?

SPECTRAFORCE is an award winning global staffing, IT services and consulting company that specializes in providing top talent and solutions for clients throughout North America and India. We pride ourselves on our partnership with our clients, MSP/VMS providers, and our employees, who have enabled us to continually be ranked as a Top Supplier in the 75+ different clients we support.

Below is the job description for your reference.

Medical Director Pharmacovigilance

6 months to start with opportunity for extension through 12/18 months

Prefer local Boston candidates but can be fully Remote

*MUST HAVE STRONG NDA SUBMISSIONS EXPERIENCE WITHIN PHARMACOVIGILANCE*

Experienced Medical Director to Provide Strategic and Hands On Development of NDA Submission Activities

OBJECTIVES:

* Oncology experience preferred

* Preferable experience with strategy for NDA submissions

* Understanding of safety data flow and data analysis for NDA submission, ability to develop timelines for documents preparation, provide hands on work in NDA submission activities, e.g., data analysis and writing of ISS, development of CCSI/CCDS and subsequent label,, participation in safety data and content verification for module 2.7.3 Summary of safety as well as module 2.5 Clinical overview-risk/benefit analysis); module 2.7.3 Summary of efficacy (safety contributes to review module 2.7.4 summary of safety; and responding to an expected barrage of ongoing queries from Health Authorities.

* Ability to work with large volume of data and TLFs is an essential skill for this position.

* Additional activities may include Clinical Study reports writing, protocol amendments writing, TLFs review and communications with biostatisticians.

* Experience in Risk Management Plan (RMP) content writing and inter-functional coordination is desirable.

* Able to quickly learn safety profile of an assigned product, perform routine PV activities like daily SAEs review, monthly signal detection (including running of reports from a safety database), preparation of quarterly safety data overview and slides preparation for quarterly safety review meetings for designated global/regional product(s), in collaboration with product global safety lead.

ACCOUNTABILITIES:

* Intimate knowledge of safety, including any emerging safety concerns and development risk/benefit profile

* Responsible for development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes but is not limited to: authorship of safety summaries to support development of the PI/SmPC, significant contribution to NDAs,

* This position will perform activities of both Senior Level PV Scientist responsible for data preparation and analysis and of Global PV physician:

- Review and oversight of safety data, both non-clinical and clinical in collaboration with an assigned product Global Safety Lead

- Review of protocols, SAPs, clinical study reports, IBs, and other documents developed for submission to regulatory authorities in collaboration with an assigned product Global Safety Lead

- Preparation and review of safety data - Participation in the development of a Risk Management Plan

- Participation in data analysis and writing of regulatory submission documents-

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

* Prefer MD, PhD, or PharmD with minimum of 6 years experience in Pharmacovigilance, experience with leading NDA submission activities is highly desirable

* Ability to work with large sets of data

* Strategical thinking and ability to make high level decisions

* Excellent oral and written communication skills including ability to present to large internal/external groups

* Good level of computer literacy with Microsoft applications * Oncology experience preferred

* Preferable experience with strategy for NDA submissions

* Understanding of safety data flow and data analysis for NDA submission, ability to develop timelines for documents preparation, provide hands on work in NDA submission activities, e.g., data analysis and writing of ISS, development of CCSI/CCDS and subsequent label,, participation in safety data and content verification for module 2.7.3 Summary of safety as well as module 2.5 Clinical overview-risk/benefit analysis); module 2.7.3 Summary of efficacy (safety contributes to review module 2.7.4 summary of safety; and responding to an expected barrage of ongoing queries from Health Authorities.

* Ability to work with large volume of data and TLFs is an essential skill for this position.

* Additional activities may include Clinical Study reports writing, protocol amendments writing, TLFs review and communications with biostatisticians.

* Experience in Risk Management Plan (RMP) content writing and inter-functional coordination is desirable.

* Able to quickly learn safety profile of an assigned product, perform routine PV activities like daily SAEs review, monthly signal detection (including running of reports from a safety database), preparation of quarterly safety data overview and slides preparation for quarterly safety review meetings for designated global/regional product(s), in collaboration with product global safety lead., * Prefer MD, PhD, or PharmD with minimum of 6 years experience in Pharmacovigilance, experience with leading NDA submission activities is highly desirable

* Ability to work with large sets of data

* Strategical thinking and ability to make high level decisions

* Excellent oral and written communication skills including ability to present to large internal/external groups

* Good level of computer literacy with Microsoft applications

Keywords: Spectraforce Technologies Inc, Cambridge , Medical Director Pharmacovigilance, Other , Cambridge, Massachusetts