Life Sucks Vayyas. Jara Help Kaavaley

[timmy]

ltt

[Johny]

epic vaccha??

[JavaBava]

bhayya interest unna fieldsanni food pettav .. take the emotions out of the equation and do watever gives enough money to keep u and ur family happy. emotional attachments to jobs, technologies and companies will lead u no where.

[JANASENA]

LTT help

[Galli_La_Lolli]

epic vaccha??

I know EPIC too 

[krypton]

Drug Safety/Pharmacovigilance Specialist 
Celldex , Inc. - New Jersey

Celldex Therapeutics seeks an experienced professional to join our company as Drug Safety / Pharmacovigilance Specialist. Potential candidates who can commute to our Hampton, NJ office are strongly preferred. For those who can commute to our Needham, MA or Branford, CT offices, periodic travel to the Hampton office will be required. Position Responsibilities:

• The Drug Safety / Pharmacovigilance Specialist will evaluate, review, and approve adverse event reports from clinical sources in accordance with FDA and ICH guidelines and Safety Management Plans: 
  • Conduct the initial reportability assessment on Serious Adverse Events (SAEs).
  • Review each report for completeness and clarity.
  • Write concise, medically accurate narratives for Individual Case Safety Reports (ICSRs).
  • Pursue follow up information appropriately.
  • Process reports to ensure all relevant timelines are satisfied.
• Assist with SAE reconciliation of the SAE report form and/or SAE database to clinical database.
• Compile and supply, as requested, safety information for Regulatory submissions such as annual reports or clinical trial reports.
• Interact with vendors, i.e., contract research organizations (CROs), as it pertains to pharmacovigilance activities and information.
• Participate in the ongoing process of improvement of company pharmacovigilance practices and procedures.
• Assist in other tasks as needed.

Required Skills:

• Must possess excellent computer skills, including data entry in a validated safety database, and experience with MS Word and Excel.
• Excellent communication and interpersonal skills are required. Must be able to effectively communicate verbally and in writing to comply with written procedures, instructions, standard operating procedures (SOPs) and other documents.
• Must be able to multi-task, work with multi-disciplinary teams, and work with strong attention to detail.
• Working knowledge of Code of Federal Regulations regarding drug safety required.
• Working knowledge of FDA and ICH guidelines related to drug safety and Good Clinical Practices required.

Education/Experience:

• Completed BA/BS degree in health science or PharmD degree, and LPN, RN, or RPh designation (or equivalent completed education and clinical designation) required.
• Must have at least 1 year (2 years’ plus preferred) of pharmaceutical or biotechnology industry experience in Drug Safety/Pharmacovigilance.
• Previous experience in processing SAEs received from clinical trials in Phases 1 to 3 preferred.

Qualified candidates interested in applying for positions at Celldex should submit a resume and cover letter, identifying the specific position to [email protected] . Celldex will make every effort to respond to inquiries from qualified applicants who have the skills and interests we are seeking. We will not be able to respond to recruiting & placement firms who contact us in an unsolicited manner, nor to unqualified applicants. Celldex is an equal opportunity employer dedicated to diversity in the workplace. 

 

[krypton]

Location:

South San Francisco, CA

Posted Date:

7/29/2014

Position Type:

Full time

Job Code:

Senior Drug Safety Associate

Salary:

Required Education:

Masters Degree

Areas of Expertise Desired:

Drug Safety, Pharmacovigilance, Regulatory,

 

Job Description Position Purpose 
The Senior Drug Safety Associate (DSA) is responsible for the collection, safety review, processing, and reporting of adverse event data for clinical trials and marketed products in compliance with applicable FDA and global regulations. This position complies with FDA / International Drug Safety regulations and internal standard operating procedures (SOPs) in all aspects of drug safety data processing and reporting. This function provides proactive safety surveillance across the lifecycle of products. This position Reports to the Director, Drug Safety & Pharmacovigilance.

Principal Responsibilities
•   Process and assess AEs from receipt to case closure in the Hyperion Argus Safety Database including narrative and ASE writing
•   Evaluate adverse event reports for content and completeness and assess for regulatory reportability
•   Ensure timely and adequate resolution of any discrepancies
•   Oversee and ensure timely and accurate processing of individual reports and safety reporting to regulatory authorities, investigators, and business partners within the required timelines
•   Assists with the revision of Standard Operating Procedures and Working Instructions for department
•   MedDRA coding of SAEs and AEs as reported in source documents of AE reports, and development/revision of MedDRA Coding Conventions, ensuring consistent data categorization
•   Coordinates and participates on projects for safety signal detection, safety analysis, and Pharmacovigilance
•   Drafting and/or contributing to FDA and global periodic safety reports
•   Communicate any issues with responsible manager(s) and offer solutions
•   Documentation of training records
•   Member of Clinical Study Team for assigned Study Protocols
•   Participates in other safety related projects as assigned and with appropriate oversight as needed
•   Collaborates well within interdepartmental team structure and environment, in particular with clinical operations, medical, and regulatory affairs
•   Collaborates with Clinical Research Organizations and Corporate Partners professionally

Requirements Qualifications
•   Health care professional (PharmD or RN) degree or equivalent
•   3+ years of relevant experience in a pharmaceutical or biotechnology company Drug Safety Department
•   The ideal candidate should have a general understanding of drug development, basic Drug Safety reporting, FDA and International Regulations for adverse event reporting, and working knowledge of the importance of regulatory compliance
•   Strong computer and database skills, experience with Drug Safety databases desired; ARGUS database experience a plus
•   Strong organizational, oral/written communication and project management skills 
•   Requires strong attention to detail and a high commitment to the quality of all projects and accountability for deliverables
•   Demonstrated ability to manage multiple projects and prioritize 
•   Ability to solve complex problems and suggest creative solutions 
•   Proactive, positive approach to work projects and constructive, supportive interactions with colleagues.

 

[krypton]

http://catalystfive.com/29123/jobs/science-biotech/drug-safety-specialist/39577?utm_source=Indeed&utm_medium=organic&utm_campaign=Indeed

[krypton]

http://www.pharmiweb.com/careers/results.asp?ROW_ID=727644&utm_source=Indeed&utm_medium=organic&utm_campaign=Indeed#.U9yDBYCVnLg

[Galli_La_Lolli]

http://www.pharmiweb.com/careers/results.asp?ROW_ID=727644&utm_source=Indeed&utm_medium=organic&utm_campaign=Indeed#.U9yDBYCVnLg

Thanks Bhayya

[krypton]

Thanks Bhayya

yayy thanks lu enduk le buddy nek work out aite padi velu.

[dummyquestion]

ltt

[alpachinao]

yayy thanks lu enduk le buddy nek work out aite padi velu.

GP

[Johny]

epic vasthe ft jobs unnayi man...like deloitte n prime ..so so...