Senior Drug Safety Associate

5+ years

Not Disclosed

Pune

10 Nov. 7, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Pharmacovigilance Associate

Location: Remote (U.S. Only)
Company: EVERSANA

About EVERSANA
At EVERSANA, we are proud to be recognized as a Great Place to Work worldwide, driven by our mission to create a healthier world. With a global team of over 7,000 employees, we provide next-generation commercialization services to the life sciences industry. We support over 650 clients, from biotech start-ups to established pharmaceutical companies, by delivering innovative solutions that bring therapies to market and improve patient lives.

We are committed to fostering a diverse and inclusive culture that thrives on unique backgrounds and experiences. Our goal is to build the future of healthcare, and we believe that together, our people make all the difference. We are EVERSANA.

Position Overview

We are looking for a Pharmacovigilance Associate to support the client Pharmacovigilance (PV) Department. In this role, you will work as both a team member and individual contributor, processing and analyzing safety data from clinical trials and spontaneous post-marketing reports. You will be instrumental in ensuring the accurate and timely reporting of adverse events (AEs) and in supporting regulatory compliance for client projects.

Key Responsibilities

Case Management and Reporting
- Support the Pharmacovigilance team in the collection, tracking, and processing of Adverse Events (AEs) from all sources, ensuring that cases are processed efficiently and accurately.
- Independently triage AEs to determine reportability, collaborating with relevant team members for clinical assessments and regulatory compliance.
- Accurately code AEs using MedDRA and WHODRUG, applying clinical judgment to ensure proper categorization.
- Perform quality control checks on case data, ensuring consistency, accuracy, and completeness in the safety database and regulatory reporting forms (e.g., MedWatch, CIOMS I).
Regulatory Compliance and Documentation
- Ensure the timely submission of expedited case reports to regulatory authorities in compliance with applicable guidelines.
- Independently draft narratives of adverse events, applying clinical judgment and standard narrative construction guidelines to ensure clarity and conciseness.
- Formulate follow-up queries and communicate with clients or stakeholders for additional information to complete case processing.
- Assist in the development and compilation of aggregate reports and other regulatory documents, as needed.
Collaboration and Leadership
- Work closely with Pharmacovigilance management, project managers, and other team members to meet client deadlines and project goals.
- Lead and guide junior team members, such as Drug Safety Associates and Drug Safety Coordinators, in case processing activities.
- Participate in regular reconciliation of serious adverse events (SAEs) between drug safety and clinical trial databases.
Continuous Improvement and Development
- Develop expertise on client products within specific therapeutic areas.
- Contribute to the creation of standard operating procedures (SOPs), work instructions, and other PV documentation.
- Stay up to date with evolving drug safety regulations and best practices, contributing to process improvements within the team.

Qualifications

Education:
- Bachelor’s degree in a life sciences discipline (e.g., Pharmacy, Nursing) is preferred.
Experience:
- Minimum of 5 years of relevant experience in pharmacovigilance, with at least 3 years in drug safety.
- Broad knowledge of domestic and international drug safety regulations, including ICH and FDA guidelines.
- Strong understanding of drug development processes and adverse event reporting.
Skills:
- Proficient knowledge of MedDRA and WHODRUG coding dictionaries.
- Familiarity with FDA and international adverse event reporting regulations.
- Strong attention to detail and ability to process complex data accurately.
- Excellent communication skills, with the ability to write clear and concise narratives.
- Ability to work independently, manage time effectively, and handle multiple tasks simultaneously.
- Proficiency in Microsoft Office and safety database software.

Cultural Beliefs at EVERSANA

Patient Minded: I act with the patient’s best interest in mind.
Client Delight: I own every client experience and its impact on results.
Take Action: I am empowered and empower others to act now.
Grow Talent: I own my development and invest in the development of others.
Win Together: I passionately connect with anyone, anywhere, anytime to achieve results.
Communication Matters: I speak up to create transparent, thoughtful, and timely dialogue.
Embrace Diversity: I create an environment of awareness and respect.
Always Innovate: I am bold and creative in everything I do.

Additional Information

Compensation: EVERSANA offers competitive salaries and benefits, with compensation determined by experience, qualifications, and geographic location (to account for cost of living).

Important Notice:
We are aware of fraudulent job offers misrepresenting EVERSANA. Please be aware that we will never request personal information or payment during the hiring process. Any suspicious activity should be reported immediately to our team.

EVERSANA is an Equal Opportunity Employer and values diversity. We believe that a diverse workforce contributes to innovation and success. All employees, regardless of race, gender, age, disability status, veteran status, sexual orientation, religion, or any other characteristic, are integral to the success of EVERSANA. Inclusion is everyone’s responsibility.

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