Senior Drug Safety Associate

5+ years

Not Disclosed

Pune

10 Dec. 5, 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 Description
At EVERSANA, we are proud to be certified as a Great Place to Work globally. Our mission is to create a healthier world. With a dedicated team of over 7,000 employees, we deliver next-generation commercialization services to the life sciences industry. We serve more than 650 clients, from innovative biotech start-ups to established pharmaceutical companies. Our products, services, and solutions help bring groundbreaking therapies to market and support patients who depend on them. At EVERSANA, we value diversity and inclusion, and every team member plays a vital role in our mission to improve lives worldwide.

Job Description
Position Overview:
This position supports the client Pharmacovigilance (PV) Department as both a team member and individual contributor, responsible for processing and analyzing safety data from clinical trials and spontaneous post-marketing reports.

Key Responsibilities:

Collaborate with PV Management and/or assigned Project Manager to meet client project deadlines.
Support other PV Associate staff in managing workload and ensuring timely reporting to Regulatory Authorities.
Participate in the development of PV and client documents, such as aggregate reports, standard operating procedures (SOPs), and work instructions.
Manage the collection of Adverse Events (AEs) from all sources, track cases through processing, and coordinate workflow for accurate reporting.
Independently triage AEs to determine reportability and collaborate as necessary for accurate clinical assessment.
Assess expectedness, seriousness, and causality according to regulatory guidelines and product reference safety information.
Code adverse events using MedDRA and medications using WHODRUG.
Conduct quality control checks for completeness and accuracy in the safety database and regulatory reporting forms.
Draft narratives based on case descriptions and follow-up queries.
Ensure timely delivery of information for aggregate reports, ad hoc compilations, and regulatory documents.
Interact with clients and stakeholders for safety data collection and reconciliation.
Lead team members to facilitate efficient case processing and perform SAE reconciliations.

Minimum Knowledge, Skills, and Abilities:

Bachelor’s degree in a life science discipline (e.g., pharmacy, nursing) is preferred.
Minimum of 5 years of relevant experience, including at least 3 years in drug safety.
Strong understanding of domestic and international drug safety regulations and industry standards.
Proficient in MedDRA and WHODRUG coding, and familiarity with FDA and international adverse event reporting regulations.
Excellent attention to detail, organizational skills, and the ability to follow established processes.
Knowledge of safety database software and Microsoft Office.

Key Attributes:

Positive attitude, strong communication skills, and ability to innovate.
Demonstrates high ethical standards, integrity, and professionalism.

Additional Information:
EVERSANA is committed to Diversity, Equity, and Inclusion and is an Equal Opportunity Employer. We respect the personal rights of all candidates and ensure confidentiality throughout the recruitment process. EVERSANA will never request personal information or payment for job applications.

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Senior Drug Safety Associate

Job Description

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