APCER Pharma

Vacancy for Delhi-based Pharmacovigilance Interns who are freshly graduated with an M. Pharm degree and seeking an opportunity to kick start their career in Pharmacovigilance.

Job Role : Pharmacovigilance Associate Qualification : B. Pharm./M.Pharm. (2022 / 2023 Batch) FRESHERS are eligible for this Job role. Job Location : New Delhi / Ahmedabad.

APCER Life Sciences is a preferred Pharmacovigilance Partner for Pharmaceutical and Biotech companies looking for compliance and adverse event reporting solutions across the drug life cycle. Our ‘Patients First’ approach enables us to deliver end-to-end drug safety, medical information, medical writing, regulatory affairs, risk management and quality assurance services globally.

Job Description – • Manage daily workload in conjunction with Manager for individual case processing, literature searches and any other tasks relevant to the Pharmacovigilance Department. • Medical review of ICSRs in APCER’s Pharmacovigilance database for the purpose of expedited/periodic submission as per the Regulations and SOPs. • Management of Compliance with the Company Standard Opera

Key Accountabilities • Assume the ability to meet the requirements of a CDA I and II with a high degree of proficiency and autonomy • Act as an independent CDM Coordinator on complex or multiple projects, CMA/CDA Coordinator on smaller projects • Manage all phases of data management activities from study start up to database close • Direct team members in daily activities • Define an

Performs Senior Review of straightforward medical writing deliverables. Negotiates timelines and discusses/resolves customer comments. You will provide written and verbal feedback to junior staff, and to customers when appropriate. Taking a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, n

Provides field support for various clinical research studies by selecting sites, performing activation duties, setting up protocols, providing training, helping to enroll participants, ensuring quality data acquisition and performing study closure activities. The key responsibilities of a CRA will include monitoring study sites and clinical activities, updating study documentation, maintaining c

Accounts for coding and abstracting of patient encounters, including diagnostic and procedural information, significant reportable elements, and complications. Researches and analyzes data needs for reimbursement. Analyzes medical records and identifies documentation deficiencies. Serves as resource and subject matter expert to other coding staff. Reviews and verifies documentation supports dia

Medical billers monitor accounts, work with patients to develop payment arrangements, and pursue delinquent accounts. They need an in-depth understanding of billing software, electronic medical records, and medical codes. Excellent written and verbal communication skills are important, as well as solid problem-solving skills, good organizational skills, and the ability to work with numbers. M

Review medical information such as attending physician statements, lab reports, paramedics exams, and/or other related underwriting information consistent per client specifications Ability to analyze a case of medical malpractice, personal injury and mass tort cases Review case narratives & queries on drug interaction and adverse effects on drugs. Detect, interpret, and update the treatment-rela

A pharmacovigilance associate monitors all products and conducts post-market evaluations to ensure drug safety. These experts are actively involved in assessing adverse event writings, updating reports on safety, conducting quality and conveying drug related case reports to appropriate authorities.

Good understanding of available libraries (in python/R/similar); ability to teach all of these to fellow team members as and when required. Ability and experience of explaining the results of data analysis to non- technical decision-makers in an actual business (non-academic) setting Proficient in MS Office suite (Word, Excel, PowerPoint, Access, Visio) Experience with SQL Server / MS Access - S

Review, analyze, and evaluate user needs to create systems solutions that support overall business objectives. Lead requirement gathering workshops with key client stakeholders from Business and IT Create Business requirements, define scope and objectives, functional specifications, develop business processes and recommendations related to proposed solution. Obtain sign-off from customers. Criti

Essential Functions • Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that don't require extensive programming expertise) with guidance. • May serv

Roles and Responsibilities Serve as a Data Operations Coordinator (DOC) for one or more protocol with less than 5 operations . Manage delivery of projects through full data management study life-cycle. Perform comprehensive data management tasks including data review, writing and resolving data clarifications. Develop and maintain good communications and working relationships with CDM t

The Clinical Data Programmer role is either part of the Clinical Data Management Systems (CDMS) group involved in clinical database build and maintenance or the Clinical Data Services (CDS) group involved in clinical data receipt, programming and delivery . CDS: The Clinical Data Programmer is responsible for supporting Clinical Data Programming Leads who serve as the lead on study specific prog