Sales Manager

Rahul Malik

#****-** *** ***** *, Mississauga, L*B 4M2

437-***-**** : adbmm9@r.postjobfree.com

OBJECTIVE

To secure a Pharmacovigilance position in a reputable organization where I can both contribute my vast knowledge and skills in this field as well as continue to grow professionally PROFESSIONAL SUMMARY

• Over 10 years’ experience in the Pharmacovigilance (PV) including managing the collection, processing, and reporting of Adverse Events (AEs) and Product Complaints

• Fully conversant with Pharmacovigilance (PV) (Including Qualified Person for Pharmacovigilance (QPPV) Services, Medical Affairs & Communications (MAC), Medical Writing (MW), Regulatory Affairs (RA), Information Technology (IT), and Quality Assurance (QA) processes and applicable regulations

• Exposure of reconciliation of ADR cases reported directly to Health Canada.

• Subject Matter Expert for PV training

• Compliant with preparation of PSURs and ASRs

• Strong capacity for handling documents pertinent to clinical information in compliance with SOP/protocol and applicable legislation

• Competent in Data entry, Quality Reviewing and medical review of patient information in ARISg, ARGUS databases

• Maintained 99.9% compliance for reporting of cases to various health authorities including heath Canada

• Familiar with triaging of cases domestic and international complaints to determine reportability based on Health Canada Medical Devices Regulations (MDR) and requirements.

• Expert in medical device pharmacovigilance and materio-vigilance PROFESSIONAL WORK EXPERIENCE

Pharmacovigilance/ Quality Assurance/Regulatory (Contract) Sept. 2019 - Present Sanis Health Care (Shoppers Drug Mart Division) • Toronto, Canada

• Screening domestic medical journals and the Canadian Vigilance Program (CVP) database for ADR’s associated with company molecules

• Data basing identified ADR’s within the PV24 database and the Quality review

• Generation of Annual Safety Reports (ASR’s) and completion of an electronic company label repository

• E-reporting and submissions to Health Canada and/or province

• Working on the Document Life Cycle Management

Pharmacovigilance Manager 2017 - 2019

APCER Life Sciences • Delhi, India

• Managed the team of 20 people (direct/indirect reporting), performance review and team management

• Supported the sales and Business Development team in building solution documents, effort estimates and pricing

• Worked as a Single Point of Contact (SPOC) for the Operations Teams, when requests for Request for proposal (RFPs) and Request for information (RFIs) are received by Sales and Business Development Teams

Rahul Malik Phone: 437-***-****

• Worked collaboratively with inside sales team and provide help as SME during initial interactions with potential clients, make specific recommendations to potential clients

• Build repository of responses to Frequently asked questions (FAQs) within RFPs and RFIs and to improve quality of the content

• Created, maintained and published a set of written procedures and best practices for the delivery of pre-sales services

• Created impactful presentations, backed by market intelligence, to support the sales / Account Owners on specific pursuits

• Interfaced with the implementation / project team, articulating customer requirement, to ensure smooth transition from Sale to Delivery

Deputy Manager-Pharmacovigilance 2009 - 2017

APCER Life Sciences • Delhi, India

• Managed daily workload in conjunction with General Manager for individual case processing, literature searches and PSUR generation

• Managed compliance with the company Standard Operating Procedures (SOPs) and regulatory requirements

• Liaised effectively and maintain excellent relationship with the clients and internal/external contacts

• Maintained awareness of changes to new regulations affecting pharmacovigilance activities

• Communicated new or changed regulations to management and to relevant members of the department in order to initiate any change in processes EDUCATION

• Post Graduate Diploma in Pharmacovigilance 2008 - 2009 Institute of Clinical Research India • India

• Post Graduate Diploma in Hospital administration 2008 - 2009 YMCA • India

• Bachelor In Dental Surgery 2002 - 2008

DJ College Of Dental Sciences • India

SKILLS

•Drug Development •ARISg •Regulatory Requirement •Regulatory Affairs •Pharmacovigilance •SOP

•Clinical Development •GCP •Project Management •Case Management •Clinical Research

•Pharmaceutical Industry •Clinical Trials •Regulatory Submissions •Budget Management •CRO

•RFI/RFP •Proposal writing •Pre-Sales Technical Consulting •Centre of Excellence •ICH-GCP

•Medical Affairs •Drug Safety •ARGUS•PV247

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