Azurity Pharmaceuticals is hiring B. Pharma/ M. Pharma/ Pharma D as a Drug Safety Associate – Apply Now

0
306
WhatsApp D. Pharma Group Join Now
Telegram D. Pharma Group Join Now
Telegram Group Latest Pharma Jobs Join Now
Telegram B. Pharma Group Join Now
Telegram Medicine Update Group Join Now
WhatsApp B. Pharma/ GPAT Channel Join Now

The Medical Affairs Group at Azurity is hiring B. Pharma/ M. Pharma/ Pharma D as a highly motivated Drug Safety Associate to join the team. This individual will report to the Director of Drug Safety and will support Pharmacovigilance activities across the organization. This individual will leverage existing industry knowledge, organizational and communication skills to support ongoing drug safety initiatives while maintaining compliance.
Position Drug Safety Associate
Qualification B. Pharma/ M. Pharma/ Pharma D./ BDS/ BAMS/ B. Sc Nursing
Experience More than 1 Years
Salary Competitive

Responsibilities:

  • Assist in maintaining compliance with Pharmacovigilance (PV) activities in accordance with company policies, SOPs, and FDA regulations
  • Assist in safety agreement editing, renewal tracking, and formatting
  • Assist with the management and oversight of safety-related information
  • Assist with individual case review and management including company-sponsored clinical trials
  • Assist with the management of the core drug safety email system
  • Assist in managing and tracking reconciliations between partners
  • Manage daily workflows and communications cross-functionally to ensure timely responses to partners
  • Assist in the review, oversight, and organization of weekly and monthly safety reports
  • Assist in organizing safety project management internal tools.
  • Assist in reviewing, organizing, and authoring standard operating procedures
  • Assist in maintaining electronic files to ensure the filing of applicable documents to ensure audit readiness
  • Assist in reviewing Expedited and Non-expedited safety reports and source documents including review for completeness and accuracy
  • Contribute adverse event information for safety reports including Periodic Adverse Drug Experience Reports (PADERs), Post-Marketing Periodic Safety Update Reports (PSURs) as well as safety data for clinical reports
  • Assist in maintaining pertinent workflows to increase the quality and submission of reports
  • Assist in the preparation and editing safety related training materials
  • Collaborate with other departments to ensure the timely processing of reports
  • Maintains the integrity of confidential information throughout the work process

Qualifications and Education Requirements

  • Bachelor’s or master’s degree in life science or healthcare-related field OR equivalent combination of education and experience (i.e., an information science degree with at least 3 years of relevant working knowledge of supporting drug and patient safety)
  • At least 3 years of experience reviewing individual case reports, aggregate reports and literature for adverse event reporting
  • Strong analytic ability to analyze and summarize the main points of case reports, studies, and/or specific topics
  • Possess experience with literature databases
  • Possess excellent communication and organizational skills and the ability to work in a fast-paced environment
  • Possess experience with safety databases
  • Problem-solving skills, especially with respect to enforcing safety rules and global procedures as described in SOPs, Operational Manuals, and Guidance Documents
  • Excellent written/oral communication skills are essential including fluency in English
  • Proactive behavior and ability to keep timelines
  • High degree of responsibility and accountability and responsiveness
  • Ability to develop cooperative working relationships with all levels of staff
  • Conversant in medical terminology
  • MedDRA coding
  • Maintains comprehensive proficiencies with Adobe Acrobat and Microsoft Office (e.g., Word, Excel, and PowerPoint) and associated modules
  • Capable of working in a team-oriented and rapidly changing environment
  • Possess a working knowledge and an understanding of FDA Regulations

Physical & Mental Requirements:

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Must be able to sit for long periods of time
  • While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
  • May occasionally climb stairs and/or ride elevators
  • The employee must occasionally lift and/or move up to 25 pounds
  • Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
  • Other miscellaneous job duties as required
Job Location Hyderabad
Job Type Full Time
Apply Online Click Here

 

MORE JOBS: Recruitment of Pharmacist/ Nurse/ Medical Officer (07 Posts) at Tata Memorial Hospital – Apply Now

<<<<<<<<<<<<JOIN US>>>>>>>>>>>>>>>>

Subscribe our PHARMACY INDIA Youtube Channel for more Pharma Updates Click Here
Follow us on Instagram Click Here
Download PHARMACY INDIA MOBILE APP from Google Play Store  Click Here
Follow us on LinkedIn Click Here

LEAVE A REPLY

Please enter your comment!
Please enter your name here