ClinChoice is Hiring Global Medical Safety Operations Physician

Job Title: Global Medical Safety Operations Physician

Job Description and Responsibilities:

Medical Review

• Non-Suspected Unexpected Serious Adverse Reaction (SUSAR) clinical trial cases for products in development

• Non-med significant Follow-up SUSARs

• Partner SUSARs (where is Company does not change the Business Partner assessment)

• SUSARs for non-company sponsored trials

• Spontaneous/ solicited individual case safety reports for products as assigned

Perform aggregate review of non-serious cases in line listings

Evaluate Individual Case Safety Report (ICSRs) for potential product quality issues (including device malfunctions, if applicable).

Watchlist

Targeted Follow-up Questionnaires

Investigator Brochure activities as assigned

Anticipated Events activities as assigned

All other operational activities that require physician input example:

• Standard Operating Procedures (SOPs),

• CAPAs

• Periodic Adverse Drug Experience Reports (PADERs)

Education and Requirements:

• A Physician (MD or equivalent), is required. A Board Certification (if US) is preferred.

• A minimum of 3 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.

• Sound knowledge of general medicine and clinical practice, and the ability to assess the clinical relevance of medical data and to interpret its clinical meaning is required.

• Experience and knowledge of Good Clinical Practices is required.

• Knowledge of pharmacovigilance regulatory requirements in US, the EU and globally is strongly preferred.

• Good communication skills (written and verbal) and the ability to work in a team-oriented, matrix environment is required.

• Significant experience and judgment required to identify and evaluate issues likely to be relevant in understanding safety profiles of a large product portfolio is required.

Apply HERE