A result oriented professional with more than 2 years of experience in Pharmacovigilance.
Well versed with both USA and EU Pharmacovigilance Processes.
Presently working with APCER Pharma Solutions Inc as Team Leader USA Process.
Complete Team Management and Leadership skills.
Well versed with VOL 9A Volume 9A of the “Rules Governing Medicinal Products in the European Union, Pharmacovigilance for medicinal products for human use”.
MedDRA coding proficiency.
ARISg (Adverse Reaction Information System Global)Expertise.
Complete knowledge of Overall Pharmacovigilance Practices for both USA and EU Processes including Case Processing, Quality Check, PSUR compilation, PADER compilation, Generation of Line-listings, Literature search among other Pharmacovigilance related work.Medical Writing :
Drafting and review narratives for the innovator clinical trial data and creating high standard scientific documents especially for oncology products. Basic training by BAYER on medical writing and narrative creation.AREAS OF EXPERTISE :Current Job profile :
The scope and scale of activities with which this job is concerned and is involved as TEAM LEAD
Managing a team of 10-12 people.
Manage daily workload in conjunction with Pharmacovigilance Manager for individual case processing, literature searches, PSUR generation and any other tasks relevant to the Pharmacovigilance Department.
Data Entry and Quality Check of ICSRs in APCER's pharmacovigilance database (ARISg) and other case management activities
Signal Detection of the ADRs with cases received for client's products
Generation and review of SOPs and WPDs
Execution of Company Standard Operating Procedures
Management of Compliance with the Company Standard Operating Procedures and regulatory requirements
Liaise effectively and maintain excellent relationship with the clients and internal/external contacts
Maintain awareness of changes to/new regulations affecting Pharmacovigilance activities. Communicate new or changed regulations to management and to relevant members of the department in order to initiate any change in processes
Builds and maintains good relationships across functional units and company affiliates
Trains and mentors new employees in pharmacovigilance
To carry out necessary administrative duties required for the job
To contact, as required, UK / US office(s) and customers/clients in order to achieve required outcomes and meet timelines
Other duties as assigned by management
To monitor and disseminate information on changes in the regulatory requirements (USA and Europe) by checking relevant websites and journals
Manage daily workload in conjunction with Medical Affairs and Pharmacovigilance Manager for individual case processing, literature searches, PSUR generation and any other tasks relevant to the Pharmacovigilance Department
Liaise with other Pharmacovigilance executives and Pharmacovigilance Officer to manage individual case processing timelines and quality check as necessary
Follow-up of serious and non-serious casesMedical Writing : Drafting and review narratives for the innovator clinical trial data and creating high standard scientific documents especially for oncology products.The scope and scale of activities with which this job is concerned and involved as Pharmacovigilance Associate :
Preparation and review of Periodic Safety Update Reports (PSURs). It also requires managing the PSUR process involving intradepartmental and interdepartmental coordination. In a span of two years, have prepared more than 90 PSURs and have reviewed 20 PSUR’s.
Review and preparation of Periodic Adverse Drug Experience Reports (PADER) for submission to USFDA.
Managing case processing by case triaging and assigning Data entry, Quality check (QC) of cases for submission to Regulatory Authorities in EEA and FDA in ARISg Database.
Processing of ADR cases in ARISg database.
Data Entry of cases done – (˜700)
Quality Control Review of cases done – (˜900)
Actively participated in audit of Pharmacovigilance system in Dec 2009 and May 2010 and was able to complete without any critical findings.
Review and verify appropriate selection of adverse events from source documents, appropriate MedDRA (Medical Dictionary for Regulatory Activities) code for each adverse event and accuracy of product label assessments for each adverse event.
Interact with client to resolve queries related to the processing of safety data.
Review the source document to assure relevant information pertaining to the case is appropriately entered into the database fields.
Handled Spontaneous cases, Prepared ADRs forms, telephonic contact record and closed the case satisfactorily.
Support to team at US office for management of adverse reaction processing process and product quality complaint handling process.
Management of the Adverse Drug Reaction processing by the team to ensure compliance to the regulatory obligations and effective case processing.
Co-ordinated in development of SOPs and working guidelines for maintaining quality standards in the work and to comply with regulations.
Query Handling. Sponsored links :
Follow-ups/Administrator work on ARISg/CPD updation /Literature articles to review/Data Entry-Quality Review/Report Scheduling of the literature articles.
Co-ordinated in preparation and review of Safety Data Exchange Agreements (SDEAs).Trainings Attended :
Training on PSUR generation
Training on MedDRA
Training on Leadership skills and effective communication
Training on “Managing Self and Others”
FDA guidance on adverse reactions and CFR regulations
Training on applicable parts of VOL 9A Volume 9A of the “Rules Governing Medicinal Products in the European Union : Pharmacovigilance for medicinal products for human use”.
Training on ARISg (Adverse Reaction Information System Global).
Training on SOPs and Guidelines.Medical Writing : Basic training by BAYER on medical writing and narrative creation for the clinical trial data especially for oncology products.PROFESSIONAL DETAILS :
Since Jan’09 at APCER Pharma Solutions as a Team Leader based in Delhi.March 2005 Oct 2008 : Ronson Pharmaceutical Ltd.
As Customer relation manager (CRM).Apr 2001-Jan 2005 : Raptakos, Brett& Co. Ltd
As Business Executive.ACADEMIA :
B.Pharma (Hons.) (Pharmacy) from Sambalpur University in 2001.
Certificate in Pharmacovigilance & Pharmacoepidemiology from Symogen, India.
MBA (Marketing) from Symbiosis, Pune (continuing through distant learning).Computer Skills :Operating system : Windows Vista, XP
MS word, MS excel, MS power point, proficient in internet research.PERSONAL Attributes :
A highly motivated, hardworking and dependable person. Punctual, reliable and willing to learn.
Able to work both independently and in a team with a good eye for detail. Able to organize and
integrate individual efforts into a team. A team player with a flair for motivating collogues. Work to ensure that internal and external timelines are met.Decalaration :
I hereby declare that all the information given above is true to my knowledge. All the documents in original/attested copies will be produced whenever required.DATE :PLACE :
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