Safety Surveillance Associate

Lifelancer


Date: 7 hours ago
City: Chennai, Tamil Nadu
Contract type: Full time
Job Title: Safety Surveillance Associate

Job Location: Chennai, Tamil Nadu, India

Job Location Type: Hybrid

Job Contract Type: Full-time

Job Seniority Level: Associate

  • Organizational Relationship(s) including to whom the position reports: Case Processing Team Lead
  • Position Purpose: Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer’s products and to meet regulatory requirements.
  • Primary Responsibilities:
  • Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays.
  • Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately.
  • Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness/listedness/labeledness); special scenarios; product complaint information; reportability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly.
  • Review case criteria to determine the appropriate workflow for case processing.
  • Write and edit the case narrative.
  • Generate reports, ensuring adherence to regulatory compliance timelines.
  • Determine appropriate case follow-up, requesting follow-up letters when appropriate.
  • Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation.
  • Develop and maintain expertise and knowledge of all products within the Pfizer portfolio; applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; and search functions in the safety database.
  • Consistently apply regulatory requirements and Pfizer policies.
  • Technical Skill Requirements:
  • Experience in pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement.
  • Demonstrated computer literacy, particularly in the use and management of relational databases.
  • Ability to achieve personal objectives while meeting departmental standards of performance.
  • Ability to work under supervision in a matrix organization.
  • Excellent oral and written communication skills.
  • Fluency in spoken and written English; knowledge of additional language(s) an advantage.
  • Experience and skill with medical writing an advantage.
  • Qualifications (i.e., preferred education, experience, attributes):
  • 0-4 year's experience in Pharmacovigilance/ Clinical research/ Hospital practice / Teaching etc.
  • Mandatory of minimum bachelor’s in health care degree (ie, dentistry, pharmacy, nursing, or equivalent).


Work Location Assignment: Hybrid

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Medical

Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

Please use the below Lifelancer link to Apply and view similar roles.

https://lifelancer.com/jobs/view/ede7581564f3ac718b52d239b01dce78

Apply on Lifelancer Platform

How to apply

To apply for this job you need to authorize on our website. If you don't have an account yet, please register.

Post a resume

Similar jobs

Team Lead, Service Operations

Kinaxis, Chennai, Tamil Nadu
20 hours ago
About KinaxisElevate your career journey by embracing a new challenge with Kinaxis. We are experts in tech, but it’s really our people who give us passion to always seek ways to do things better. As such, we’re serious about your career growth and professional development, because People matter at Kinaxis.  In 1984, we started out as a team of three...

Software Engineer 3 - Mobile

MX, Chennai, Tamil Nadu
21 hours ago
Life at MXWe are driven by our moral imperative to advance mankind - and it all starts with our people, product and purpose. We always carry a deep sense of drive and passion with us. If you thrive in a challenging work environment, surrounded by incredible team members who will help you grow, MX is the right place for you.Come...

Specialist Blades

Vestas, Chennai, Tamil Nadu
1 day ago
Do you want to be at the core of making the world more sustainable? Do you have a deep understanding of the entire lifecycle of wind turbine blades, bringing a focus on stakeholder management and technical expertise? This is an exciting opportunity to be part of a company on the forefront of innovating renewable energy technologies.Service > Global Service Operations...