Department: PV (Clinical Operations)
- Reviews the Adverse event case narrative, coding, product/Indication, labeling in accordance with the respective reference safety documents, causality and Medical history for medical completeness, accuracy, and overall medical content.
- Analyze medical data to investigate causes and treatment of toxicity, pathogens, or chronic diseases and adverse event reaction caused due to drugs given for medication.
- To Review and provide PV therapeutic area input for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents
- Review a Line Listing of cases and evaluates the coding and labelling and confirm the events are evaluated correctly.
- Manage review of cases according to internal timelines
- In conjunction with pharmacovigilance scientists and physicians contribute to writing and maintaining Risk Management Plans.
- Contribute to solving reconciliation medical coding issues/discrepancies
- Review and update generated follow-up letters for the prescribers and investigators as appropriate.
- Responsible for Company sponsored clinical trials, confirms that a case is a SUSAR case or an otherwise expeditable report which requires unblinding
- Responsible to support in preparing aggregate safety data reviews for pre-and post-marketing ASRs including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development safety Update Reports (DSURs), IND annual reports, and other Ad-hoc reports
- Liaise with marketing team(s) to evaluate safety impact and provide input into program design (e.g., social media, market research, patient support programs).
- Assist in writing and/or reviewing of monthly safety signal reports
- Demonstrated qualities of competency, accountability, initiative, and leadership
- Experience in process improvement initiatives
- Extensive knowledge of US, ICH and EU PV and GCP regulations
- Excellent strategic decision-making and analytical skills
- Computer skills including proficiency in use of Microsoft Word, Excel & PowerPoint
- Strong leadership skills with excellent track record
- Strong verbal, writing and organizational skills, including good command of English
- Experience with Regulatory Authority Inspections (PV and GCP)
- Experience working with vendors
Educational and/or experience requirements:
A physician (MD or equivalent) with 3 +years pharmaceutical experience preferably performing Medical Review. Ability to critically evaluate safety data from multiple sources (clinical trials, literature, etc.), assesses clinical importance and potential strategic impact of the data and present the findings clearly in both written and oral communication is required.
Job Type: Full-time
Salary: $100,000.00 to $120,000.00 /year
Please send profile at firstname.lastname@example.org for direct consideration or question.