Stephen Ohimor, Pharmd, Capm Email & Phone Number

United States

United States

Global PV Operations / Risk Management, and Medical Information Services: aggregate safety reports (PBRER, DSUR, PADER), signal detection / RMP contribution; quality and compliance evaluation for audit and inspection readiness.

Performed PV Operation & Risk Management activities and oversight of major CROs and global partners activities - development of safety data exchange agreement (SDEA -global and local), SOPs (global/local), CCDS (CCSI) updates with clinical overview; performed company case assessments and comments; managed clinical safety & post-marketing safety reports, improving ICSR / MedDRA coding efficiency; contributed to REMS development and managed periodic reports (PADER, DSUR,PSUR /PBRER,) preparation & reporting, strategies for quality assurance and audits for regulatory compliance; assessment/causal relationship of ICSRs; signal detection and trends analysis, developed & updated CCDS / SOP, concise narratives / review of SAE for medical content, accuracy, and completeness; developed follow-up queries for cases of interest, MedDRA coding / review; audit support / regulatory inspection preparation; ad hoc regulatory responses, and product monograph update support). medical communications (medical information / drug promotion material review, created standard response documents) subject matter expert / resource professional for different therapeutic areas; development of data conventions for global use and management of PV operations budget.Contact: oscaeme44@comcast.net

Leverkusen, North Rhine-Westphalia, De

Safety reports review / interpretation of safety data for medical significance and causality evaluation; MedDRA / WHO DRUG coding and review; safety reports narratives / periodic safety reports review. Patient therapeutic monitoring / drug interactions review/ Individual patient REMS review / follow-up pharmaceutical care practice.

Clinical / Post-marketing / literature safety reports review/evaluation; causality assessment / medical relevance/or significance evaluation; oversight of case quality / narratives review & update, events of interest, critical labs interpretation, complex patient hospital records review / data extraction; collaboration with safety physicians, compliance and CAPA team for issues resolution; patient-specific events / risk evaluation. Global and local business partners PV exchange.

Leverkusen, North Rhine-Westphalia, De

Medical safety review and case comments; case quality review / oversight, causality review/ comments. MedDRA coding review/ case narraitive improvement.

Post-marketing / literature safety reports evaluation / assessment/ quality case review; Patient Support Program - safety reports / pregnancy cases - local / global case assessment.

Cambridge, Ma, Us

Safety reports assessment / evaluation / safety narrative writing / follow-up with reporters.

Drug safety services and operation management- case quality oversight, periodic reports review /comments; causality assessment /evaluation; global periodic reports collaborative regulatory reporting; ad hoc reports / risk evaluation / regulatory inspection discussion - Point person for Inspection results.

Management of pharmacovilance system/services, global implementation with partners;management of medical services, marketing /Sales/ NAM support. Implementation and management of Product Label Safety Review Committee / product risk evaluation. Clinical and post-marketing safety reports assessment / evaluation; periodic safety reports preparation; product promotional material review. IB and CCSI review / updates.

Leverkusen, North Rhine-Westphalia, De

Implementation and creation of medical information database of standard professional response documents;Adverse events coding, using MedDRA.

Managed workload and personnel,medical information database implementation,creation of response documents / inquiries and safety reports; publication, CME & promotional materials review in collaboration with partners, management of vendors, and ad hoc regulatory response documents preparation.

Managed oncology and HIV products; medicalcommunications/collaboration with ScienceLiaisons/co-promotion partners.

Pharmacokinetics services & patients / drug treatment evaluation; students /residents training & CE presentations; studies on seizure prophylaxis in head trauma patients, Medical rounds with residents and patient charts review.

Doctorate Degree (Pharmd), (Applied Therapeutics And Diseases)

Bachelor Of Science (Bsc), Pharmacy

Certification From Project Management Institute, Project Management

B.A., Chemistry