Senior Drug Safety Associate

5+ years

Not Disclosed

Pune

10 Dec. 12, 2024

Job Description

Job Type: Full Time 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

Company Overview:

At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. Our mission is to create a healthier world by delivering next-generation commercialization services to the life sciences industry. With a global team of more than 7,000 employees, we serve over 650 clients ranging from innovative biotech startups to established pharmaceutical companies. Together, we make an impact every day, bringing innovative therapies to market and supporting the patients who depend on them.

We embrace diversity in all its forms, fostering an inclusive culture that values different backgrounds and experiences. Our goal is to improve patient lives worldwide, and we need people from all walks of life to help us build the future of healthcare. We are deliberate in building a team that is not only skilled but also cares deeply about EVERSANA, our people, clients, and most importantly, the patients we serve. We are EVERSANA.

Position: Pharmacovigilance Associate
Location: [Insert Location]
Job Type: Full-time

Job Description:

The Pharmacovigilance Associate supports the client Pharmacovigilance (PV) Department in processing and analyzing safety data from clinical trials and post-marketing reports. This position is integral to ensuring the safety of pharmaceutical products and compliance with regulatory guidelines.

Key Responsibilities:

Case Management: Work closely with PV Management and Project Managers to meet client project deadlines and support case management activities. This includes collecting and tracking Adverse Events (AEs) and ensuring timely reporting to regulatory authorities.
Adverse Event Reporting: Triage AEs independently to determine reportability. Assess expectedness, seriousness, and causality in compliance with regulatory guidelines. Perform data entry in the safety database and create accurate narratives for reports.
Regulatory Compliance: Ensure timely submissions of expedited case reports, quality control checks of regulatory reporting forms, and reconciliation of serious adverse events (SAEs) in clinical trials.
Client and Stakeholder Communication: Interact with clients and stakeholders for safety data collection, data reconciliation, and other project-related activities.
Team Leadership: Lead and support team members, such as Drug Safety Coordinators, to ensure efficient case processing and compliance with timelines.
Document Development: Assist in the development of aggregate reports, standard operating procedures, and work instructions. Provide assistance in regulatory document compilations and other reporting as requested.
Therapeutic Area Expertise: Develop expertise in client products and therapeutic areas to contribute effectively to case management and reporting.

Minimum Qualifications:

Education: A BS degree in a life science discipline (e.g., pharmacy, nursing) is preferred.
Experience: Minimum of 5 years of relevant experience, with at least 3 years in drug safety and pharmacovigilance.
Knowledge: Broad knowledge of domestic and international drug safety regulations, industry practices, and standards. Strong attention to detail and understanding of medical terminology.
Skills: Experience with MedDRA and WHODRUG coding dictionaries. Familiarity with FDA and international adverse event reporting regulations is a plus. Excellent organizational skills and the ability to follow established processes.
Technology: Proficiency in safety databases and Microsoft Office applications.

Additional Information:

Fraud Prevention Notice:
Beware of fraudulent job offers that misrepresent EVERSANA. We will never request personal information or payment during the hiring process. If you encounter suspicious offers, please report them immediately.

Diversity, Equity, and Inclusion:
EVERSANA is an Equal Opportunity Employer. We value diversity in all its forms, including race, gender identity, age, disability, veteran status, sexual orientation, religion, and more. We believe inclusion is everyone’s responsibility, and diverse perspectives are essential to improving patient lives and driving innovation in healthcare.

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Senior Drug Safety Associate

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