Lovish Marwaha, M. Pharm. Email & Phone Number

Canada

•Expertise in processing Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.• Trained in performing Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information.• Determining initial/update status of incoming events.• Expertise in database entry including MedDRA AE coding and Product coding via WHO drug dictionary, writing narratives, Literature related activities, Quality review, assisting with reconciliation, case closure related activities, coordinating translations, as per internal/ project timelines. • Trained in assessing Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to meet requirement as per project. Liaise with relevant stakeholders to facilitate expedited reporting.• Liaise with manager for regulatory tracking requirements and electronic reporting.• Ensure compliance to all project related processes and activities.• Provide and impart technical and process information to Safety Management and members of operational team on project specific issues.• Establish and maintain effective team and project service operations communications i.e. provide regular feedback to operations team manager and other relevant stakeholders on project metrics, out of scope work challenges/issues and successes.

Winnipeg, Manitoba, Canada

- Maintained records by recording and filing physicians' orders and prescriptions- Confirmed accuracy of all pertinent prescription information prior to filling- Created and updated patient profiles (Healthwatch)- Performed third party adjudications- Accurately dispensed prescription medications- Maintained pharmacy stock through inventory control systems- Handled general OTC inquiries from patients and referral to Pharmacist where required and necessary- Assisted with cashier responsibilities as required in the Pharmacy- Generated revenues by calculating, recording, and issuing charges- Contributed to team effort by accomplishing related results as needed

Chandigarh

• Managed adverse events reporting of all case types (international clinical trials Phase I to Phase III, Medical devices, Literature articles, Patient support programs, Post marketing surveillance studies, E2B, Health authority cases, Courtesy and Social media, Market research studies) of full spectrum of diseases and disciplines including different types of cancers, genetic disorders, immune system disorders.• Primarily performed quality review of adverse event for accuracy and completeness.• Prepared safety reports and utilized regulatory and medical knowledge to assess claims.• Proficient in Drug safety database like Argus Safety and AWARE database• Managed case related information including lab results, and procedures as well as compiled complete narrative summaries.• Trained and mentored PV scientists in various activities of case processing and good pharmacovigilance practices.• Expertise in MedDRA drug dictionary coding and obtained detailed information in prevention of quality assurance discrepancies.• Working knowledge of Artificial intelligence database i.e. ConvergeHealth Safety

Chandigarh

• Provided medical inputs for assessing and capturing adverse event/events reports associated with client products on a worldwide basis on client’s drug safety database, all performed in accordance with international and local regulatory requirements as Case Medical Evaluator. • Data entry of Individual Case Safety Reports (ICSRs) in the safety database, including determining the expectedness of adverse events against various labeling documents (such as RSI, SmPC, CCDS, IBs etc.) writing case summaries, assessing causalities if required and writing company comment if required as Case Data Manager.• Reviewed individual case safety reports (ICSR) for accuracy of the data captured on the client’s database per relevant quality guidelines and procedures. • Management of ICSRs of all types of cases (spontaneous, post-marketing surveillance, clinical studies and solicited programs) and excellent knowledge of AE Safety Profile of assigned drugs, Reference Safety Information Documents, Data Entry Conventions, Guidelines, and International Drug Safety Regulations. •Special expertise in processing Literature Cases including cases from Medical Journals Abstracts, Poster Presentation, Literature Summary Cases, Eudravigilance Medical Literature Monitoring Tool (EMA-MLM) and full Literature Articles including Clinical trial study cases and Spontaneous Reports. •Experienced in the use of various drug Safety databases (primary expertise in AWARE & ARGUS) and in handling Enterprise Resource and Planning (ERP) tools.

Jalandhar, Punjab, India

- Handled the management of Urology and Gynecology portfolio- Built marketing strategies and enhanced the sale of Pharmaceutical products - Conducted marketing activities and training sessions for sales team

Chandigarh

- Completed research work on the project entitled as "Pharmacotherapeutic potential of TRPV Channel antagonist on stavudine induced neuropathic pain".- Published two publications related to the research work on role of TRPV Channel on stavudine induced neuropathic pain.

Chandigarh, India

-Learnt the various concepts about prescription of drugs, the principles of rational and irrational prescription and the process of prescription of drugs.-Went through rigorous training on correct and effective ways of prescription and how it is linked to the well being of the patients.-Monitored the major prescription trends of Anti-Hypertensive and Anti- Diabetic Drugs.

Chandigarh

-Collected the data regarding Adverse Drug Reaction via Adverse Drug Reaction forms-Analyzed the Adverse Drug Reaction for reporting to WHO via VIGIFLOW database

Amritsar

-Learnt about the basic quality control test of Pharmaceutical products-Performed basic quality control test of Pharmaceutical products

Master Of Pharmaceutical Sciences (M.Pharm), Pharmacology, A

Activities and Societies: Placement Cell Member of UIPS Volunteeer In DST Inspire Camps Volunteer in IBRO-APRC school, symposium.

Bachelor Of Pharmacy (B.Pharm.), Pharmaceutical Sciences, A+

Activities and Societies: Class representative, Meritorious studentBachelor of Pharmacy