Abubaker Mohammed
Wakefield
Summary
Enthusiastic, hardworking drug safety professional seeking to obtain a challenging position providing professional growth in the pharmaceutical industry.
Highly skilled and experienced Medical Safety professional with 14+ years of experience in Multiple Therapeutic Areas, Good Clinical Practice (GCP), Pharmacovigilance and Clinical Research. Demonstrated expertise in determining the safety profile of assigned registered / marketed products through the medical assessment of adverse events/reactions and product complaints. A keen analyst and strategist with proven abilities in providing essential safety expertise for decisions related to aggregate reports, responding to requests from Regulatory Authority. Strong team leader capable of fostering an atmosphere that encourages highly talented professionals to balance high level skill with maximum productivity.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Safety Medical Director
Immedica (former Neurocrine, UK LTD)
01.2023 - Current
- Medical review and case assessment of postmarketing/clinical ICSRs, including assessment and quality control of coding of preferred terms, medical history, and treatment medications; determination of seriousness, causality, and expectedness; narrative review; query generation; and follow-up of SAEs (ARGUS, ARISg databases).
- Compose a sponsor comment or summary. Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements.
- Contribute to the drafting of aggregate reports (DSUR, PBRER, PSUR).
- Contribute to the preparation of safety information in labelling documents.
- Contribute to renewal and new indication expansion activities.
- Review signal detection reports, line listings, and CIOMS in advance of the signal review meeting.
- Respond to regulatory authority requests.
- Attend Recall committee meetings.
- Assist in the creation, review, and implementation of documents and/or tools to align and improve pharmacovigilance processes (SOPs, working practices).
- Participate in any audits or regulatory inspections as required.
- Provide oversight of medical-related queries and monitor the ICSR quality issues of the CRO.
- Performed operations activities (reviewing work orders, invoices, and SDEA updates).
- Provide support to QPPVs/LPPVs as required.
- Act as Global Safety Physician, and back-up for assigned products.
Physician Medical Reviewer
ProPharmagroup, UK
12.2021 - 12.2022
- Perform medical review of serious individual case safety reports.
- Provide input into a system or process to allow for detecting changes or potential changes in the safety profile of the client’s product(s).
- Review signal detection reports and participate in signal review meetings as required.
- Maintain an awareness of current legislation associated with pharmacovigilance requirements.
- Participate in any client, and/or regulatory inspection or audit, as required.
- Worked on the COVID-19 vaccine project.
Sr. Medical Safety Advisor
IQVIA, Bangalore, India
Bangalore
09.2015 - 09.2021
- Medical review and case assessment of SAEs, including assessment and coding of preferred terms, medical history, and treatment medications; determination of seriousness, causality, and expectedness; narrative review; query generation, and follow-up of SAEs; write company comments.
- Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases.
- Serve as an internal consultant to Safety Management, case processing teams, and projects being supported.
- Present safety and clinical data review findings during client meetings.
- Ensure coverage for all medical safety deliverables within regulatory or contracted timelines.
- Maintain awareness of medical safety, regulatory developments in the industry.
- Ensure timely follow-up and resolution of compliance issues.
- Served as Subject Matter Expert (SME).
- Served as Point of Contact/Back-up Point of Contact for medical team members or at programme level.
Senior Pharmacovigilance Physician
Quintiles, Bangalore
Bangalore
04.2013 - 02.2014
- Thoroughly reviewed individual case safety reports comprising of spontaneous and solicited reports to ensure safety and seriousness of the assigned product.
Co-Investigator
Bibi General & Cancer Hospital, Hyderabad
Hyderabad
04.2012 - 04.2013
- Extended necessary assistance to investigator and ethics committee in overseeing multiple functions including: Subject identification and selection, Writing of source documentation, Pretrial procedures and Informed consent, Trained and mentored study coordinators, Coordinate with CRAs; Medical monitor Central lab, IVRS, Central ECG vendors
Research Assistant
William R. Sharpe, Jr. Hospital
01.2011 - 01.2012
Research Assistant
West Virginia University
01.2008 - 12.2010
Duty Medical Officer
Care Multi Specialty Hospital, New Delhi
New Delhi
11.2005 - 05.2007
Medical Intern
Mamata Medical College, India
05.2004 - 05.2005
Education
Masters - public health
West Virginia University
01.2010
Bachelors - Medicine
Mamata Medical College
India01.2005
Skills
- Medical review
- Aggregate reports (PSUR, PBRER, DSUR)
- CRO and Partner Management
- Regulatory Authority communications
- Signal Management Team
- Support QPPV and LPPV
Custom Section
- Work Permit for UK (Indefinite leave to remain)
Affiliations
- Member of Indian Medical Association, India
- Member of Andhra Pradesh State Medical Council, Andhra Pradesh, India
Languages
English
Proficient
C2
Hindi
Upper Intermediate
B2
Certification
- ECFMG Certified
Timeline
Safety Medical Director
Immedica (former Neurocrine, UK LTD)
01.2023 - Current
Physician Medical Reviewer
ProPharmagroup, UK
12.2021 - 12.2022
Sr. Medical Safety Advisor
IQVIA, Bangalore, India
09.2015 - 09.2021
Senior Pharmacovigilance Physician
Quintiles, Bangalore
04.2013 - 02.2014
Co-Investigator
Bibi General & Cancer Hospital, Hyderabad
04.2012 - 04.2013
Research Assistant
William R. Sharpe, Jr. Hospital
01.2011 - 01.2012
Research Assistant
West Virginia University
01.2008 - 12.2010
Duty Medical Officer
Care Multi Specialty Hospital, New Delhi
11.2005 - 05.2007
Medical Intern
Mamata Medical College, India
05.2004 - 05.2005
Masters - public health
West Virginia University
Bachelors - Medicine
Mamata Medical College