Executive Medical Affairs-Clinical Research Pharmacovigilance
The Searle Company Limited
Total des années d'expérience :9 years, 2 Mois
Medico-Marketing & Regulatory
• Spearhead in all aspects of New Product Commercialization including; preparation of Summary of Product Characteristics (SmPC), and product Leaf insert, Artwork text approval as per International Standards and guidelines (EMA, FDA, MHRA & BNF).
• Involved in development of new framework, SOP’s and Manuals to provide improved services to different Searle Business Division (subsidiary).
• Ensured that all Therapeutic Areas related Promotional Material (Visual-Aid, Drop card, doctor’s letter etc.) are in accordance to the international standards.
• Successfully handled the training related tasks; Planning, scheduling, preparing and updating training manuals.
• Involved and successfully completed the MQCM inspection and audit readiness by assisting in Internal Quality Review and maintaining audit related documentations.
• Assisted in Field-based Medical to Medical Communication through initial meetings to HCP’s, provided Disease and product related presentations to the Key Opinion Leader (KOL)
• Provided medical Input in Commercial Activities-involved in reviewal promotional Materials for assigned TA/Products
• Recruited to respond to Medical Information Inquiries from Healthcare professionals.
• Successfully developed 12 initial phase presentations realted to CMEs and Scientific Conferences.
Pharmacovigilance
• Appointed as a Pharmacovigilance lead: handling adverse-event case reports, conducting follow-ups and notifying cases timely to the regulatory department.
• Responsible for recording and maintaining the Pharmacovigilance database system through entry of each case reported with its status.
• Successfully passed two outsource audits for Pharmacovigilance.
Reviews scientific literature and bibliographic sources.
Developed and designed an Adverse Event Reporting Form for Company through CIOMS.
Evaluate safety profiles and ensured document filing and archiving.
Responsible for the safety reports received from the post- marketing sector identification & reporting in accordance to the ICH-GCP standards & also by the standard operational procedures.
Ensured compliance of Pharmacovigilance activities to standards, conducting case reconciliation with concerned departments, taking part in audits and inspections.
Successfully passed two outsource audits for Pharmacovigilance
Pharmacovigilance Training-Trained the Searle Employees on Pharmacovigilance including Detection, assessment and Reporting through Adverse Event Form.
Medical Affairs Associate
• Responsible in assisting for compliance of Pfizer policies, procedures and local regulatory requirements in following areas;
o Medical Affairs
o Local research projects
o Medical Information System
o Regulatory operations
o Product Safety
o Successfully handled the training related tasks; Planning, scheduling, preparing and updating training manuals.
• Involved and succesfully completed the MQCM inspection and audit readiness by assissting in Internal Quality Review and mantaining audit related documentations.
• Assisted in Field-based Medical to Medical Communication through initial meetings to HCP’s, provided Disease and product related presentations to the Key Opinion Leader (KOL)
• Provided medical Input in Commercial Activities-involved in reviewal promotional Materials for assigned TA/Products
• Recruited to respond to Medical Information Inquiries from Healthcare professionals.
• Successfully developed 12 initial phase presentations realted to CMEs and Scientific Conferences.
Trainee
Worked on QMS(Quality Management System)
• Assisted in pre-audit of Documentations & mantaining Records
Sanofi-Aventis Pakistan Limited karachi, Pakistan
October-2014 March-2015
• Trained and planned monthly Stability of products
• Worked successfully on Stability chamber project as a trainee lead.
• Managing proper preperation of Reagents as well as proper storage
• Mantaining Lab in accordance with SOP’s and GLP
• Raw and Finished good Analysis following Standard testing methods using equipments HPLC, GC, UV spectophotometer etc.
Trained In Sanofi Aventis
• Good Laboratory Practice (GLP)
• Good Documentation Practices (GDP)
Development of pharmaceutical care, plan, problem solving, decision making and active participaton in a Medical team
•Participation in Pharmacotherapy and Rational use of Medicine
•prescriptions for any Drug interaction and rational use of medicine
•Interacting with Physicians, Patients and paramedical staff about drug therapy
•To solve queries of other group members and reporting to the Head about their performances
•Giving presentations on Drug-drug interactions, diseases etc
Abbasi Shaheed Hospital/Karachi,
Pakistan
Summary of Project Experiences
Clinical Research
POST MARKETING OBSERVATIONAL STUDY (PMOS)
Gastroenterology/ PMOS on Hepatitis C/Multicentre-
•Project Lead/Review of Medical writing/ Review and assist in preparation of essential Study documents, Monitoring of Sites, Communication with Investigators, Maintainence of Study Related Trackers.
Pain Segment/PMOS on Pain with fever/Multicentre-
•Review and in Medical writing/ Revieew and assist in preparation of essential Study documents, Monitoring of Sites, Communication with Investigators, Maintainence of Study Related Trackers.
Gastroenterology-ICU Care Patients/ Post Authorized Safety Study (PASS) on Nutritional Supplement/Single centre
• Project Lead/Review, Communication with Investigators, Maintainence of Study Related Trackers, Study related Presentations, Training of staff on ICH-GCP, Site Initiation Visit and site monitoring.
Bioequivalence Project
•Site selection, Correspondence with the International CRO’s, Finalization of Qoutations, Reviewing BE study protocols received from CRO and ensuring its completeness with respect to scientific and regulatory requirements.Finalizing study specific task order with the selected CROs.Co-ordinate with the CROs for proper execution of BE studies. Co-ordinating for import license and BE NOC with the regulatory team.
Pharmacovigilance Project
•Conduct Trainings all over the country for awareness of Pharmacovigilance.
•Preparing monthly update reports for submission to Regulatory Authorities.
•Mantaining a PV Database for the reportings of Adverse events. Archieving and maintaining the documents for audit porpose.
•To assist in preparations of PV SOP’s.
Masters in Health & hospital Management
Pharmacy , Medicine
Pre-Medical