Pharmaceutical Safety Professional

4 days ago

Pune, Maharashtra, India EVERSANA Full time
About EVERSANA

At EVERSANA, we strive to create a healthier world by delivering next-generation commercialization services to the life sciences industry. Our global team of over 7,000 employees is committed to bringing innovative therapies to market and supporting patients who depend on them.

We serve more than 650 clients, ranging from biotech start-ups to established pharmaceutical companies, and are grounded in our cultural beliefs. Improving patient lives around the world is a priority, and we need people from diverse backgrounds to help build the future of healthcare and the life sciences industry.

The Role

This position supports the client Pharmacovigilance Department as both a team member and individual contributor in processing and analyzing safety data from clinical trials and spontaneous post-marketing reports.

You will work closely with PV Management and/or assigned Project Manager to facilitate and meet client project deadlines. Additionally, you will provide support to other PV Associate staff to efficiently manage workload and ensure timely reporting to Regulatory Authorities and others as required.

This role may also involve participating in the development of other EVERSANA-PV and client documents such as aggregate reports, standard operating procedures, and work instructions.

Main Responsibilities
  1. Facilitate and meet client project deadlines working closely with PV Management and/or assigned Project Manager.
  2. Provide support to other PV Associate staff to efficiently manage workload and ensure timely reporting to Regulatory Authorities and others as required.
  3. Participate in the development of other EVERSANA-PV and client documents such as aggregate reports, standard operating procedures, and work instructions.
  4. Collection of Adverse Events (AEs) from all sources, tracking of cases through case processing activities, and coordinating workflow activities to promote accurate reporting and efficient time management.
  5. Independent triage of AEs to determine reportability, not excluding collaboration with relevant team members as may be required to establish an accurate clinical assessment of the case and process information on reported adverse drug and device experiences.
  6. Independently assess expectedness, seriousness, and causality in accordance with regulatory guidelines and product reference safety information.
  7. Independently code adverse events in MedDRA using clinical judgment and medications to WHODRUG.
  8. Perform a Quality Control check for completeness, accuracy, and consistency of information in the safety database and on regulatory reporting forms (e.g., MedWatch, CIOMS I).
  9. Independently create a draft narrative of the event(s) based on the description of the case provided by the reporter using a standard narrative construction guide; apply basic rules of grammar to improve the narrative content.
  10. Independently formulate follow-up queries.
Requirements

To be successful in this role, you should have:

  1. A BS degree in a life science discipline (e.g., pharmacy, nursing).
  2. 5 years of relevant experience, including 3 years in drug safety.
  3. Broad knowledge of domestic and international drug safety regulations, industry practices, and standards.
  4. Strong attention to detail, teamwork, and initiative.
  5. Excellent working knowledge of MedDRA and WHODRUG coding dictionaries.
  6. Familiarity with FDA and international adverse event reporting regulations per ICH guidelines.
  7. Understanding of medical terminology and familiarity with principles of adverse event reporting in the pharmaceutical industry.
  8. Must be quality-oriented and demonstrate consistent attention to detail.
  9. Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required.
  10. Must have good planning and organizational skills.
  11. Knowledge of relevant software, including safety databases and Microsoft Office.

In exchange for your expertise, we offer a salary range of $85,000 - $110,000 depending on experience.

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