Safety Surveillance Physician

JOB DESCRIPTION

Safety Surveillance Physician

12 month contract

Remote

Rate: Open

Job Description

The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall Pharmacovigilance process.

The Safety Surveillance Physician (SSP) has primary responsibility for determining the medical and scientific relevance of adverse event reports within the context of the product's safety profile as well as other products within the same therapeutic area. These responsibilities include spontaneous reports, clinical and non-clinical studies, literature reports and other sources of safety data.

• SSPs are responsible for the medical assessment of case level and aggregate safety data for new safety concerns and trends and the communication of these issues to the SSP Team lead. Additionally, SSPs participate in matrix management activities (e.g. Safety Management Team) and provide pharmacovigilance expertise on individual case reports. SSPs support activities such as evaluating safety issues from various sources including Designated Medical Events (DME) and Events of Interest (EVOI), preparation of aggregate safety reports such as PBRERs, ad-hoc regulatory reports, Risk Management Plans, and interpretation of surveillance and product quality data.
• The Director, SSP has additional responsibility to play a significant role as a senior technical leader of internal and external business initiatives.
• The Director, SSP will also support Vendor Oversight for vendor physicians.

PRINCIPAL RESPONSIBILITIES:

o Analysis and assessment of SUSARs

o Analysis and assessment of Critical Cases (DME, EVOI, etc.)

o Detect single case signals/through validation

o Member of Safety Management Team

o Actively participate in Signal Evaluation

o Ensure Follow-up of all critical case/ Events of Special Interest (RMPs identified risks)

o PBRER activities

o Investigator Brochure activities

o Vendor oversight, including participation in QC activities

EDUCATION & EXPERIENCE REQUIREMENTS: Describe the minimum knowledge, skill and ability requirements for the position. Include any degrees or certifications which are required and/or desirable.

• A Physician (MD or equivalent), is required. A Board Certification (if US) is preferred.
• A minimum of 6 years of experience in industry, academia or patient care settings is required.
• Direct experience in pharmacovigilance is strongly preferred.
• A minimum of 2 years in clinical practice after postgraduate training program is preferred.
• Experience and knowledge of Good Clinical Practices is required.
• Knowledge of pharmacovigilance regulatory requirements in US, the EU and globally is strongly preferred.