Product Safety Specialist

FlexBoard; India; On-site; INR 600,000 - 900,000; Full time

Job summary

FlexBoard seeks a pharmacovigilance professional to manage safety information for marketed and investigational products, ensuring accurate reporting and timely communication with health care professionals and consumers.

The role involves coding adverse event data in ARISg, contributing to regulatory submissions, and maintaining knowledge of product literature and SOPs to ensure compliant case handling.

Qualifications

• Bachelor's degree in Medical field required. Minimum 2–4 years in industry pharmacovigilance or drug safety.
• Experience in verbally interviewing health care professionals and consumers.
• Strong medical terminology and patient-care standards.
• Computer proficiency and ability to manage regulatory timelines.

Responsibilities

• Responsible for receipt and documentation of Safety information for Marketed and Investigational Products.
• Interacts with health professionals and consumers to obtain and follow-up reports of possible adverse events.
• Codes and enters information into the global safety database (ARISg).
• Creates and ensures distribution of regulatory reports for FDA and other health authorities.

Skills

Attention to detail

Verbal interviewing

Medical terminology

Health care communication

Data entry accuracy

Education

Bachelor's degree in Medical field

RN/RPh/PharmD/MD licensure

Tools

ARISg

MedDRA coding

Job description

Responsible for receipt and documentation of Safety information for Marketed and Investigational Products. Interacts with health professionals and consumers to obtain and follow-up reports of possible adverse events with company products. Provides product information to health care professionals, consumers, and sales representatives. Codes and enters information into the global safety database. Verifies the accuracy, completeness and validity of information for reputed company adverse event report for which he/she is responsible. Assures consistency of case records and documentation. Creates and ensures distribution of regulatory reports for FDA and other regulatory health authorities. Accurate and reputed company data entry of both domestic and foreign adverse event and serious adverse event information into the PSSS (Product Safety Surveillance reputed company) consistent with the ARISg coding reputed company, SOPs/WIDs, process flows and established time frames reputed company the ARISg workflow. Full understanding of the products company reputed company Data sheet, PI, and/or IB for accurate labeling and listedness. reputed company appropriate and reputed company follow-up per department guidelines, including accurate and thorough communication documentation reputed company the case. Maintain proficiency in the utilization of the PSSS, including MedDRA coding. This may include participating in the validation process for the PSSS. Ensure accurate and reputed company submissions to regulators, co-marketing partners and affiliates reputed company company and regulatory timeframes. Utilize ARISg for reputed company reporting and confirmation of successful distribution and acknowledgement. Maintain sufficient knowledge of reputed company company products to ensure reputed company and knowledgeable discussions with consumers and reputed company providers and dissemination of accurate product information in response to queries. reputed company high level customer service to consumers, health care professionals and internal customers. Complete reputed company required training reputed company the timelines provided so as to ensure knowledge of reputed company relevant corporate and departmental SOPs, SWPs and WIDs. Ensure timeliness in regulatory compliance reputed company sufficient information to assess the medical reputed company of an adverse event report, while at the reputed company time assuring the information provided adequately addresses the concerns of the health care provider and/or consumer.

Required Qualification & Skills

Bachelors degree in Medical field with RN or RPh licensure, or PharmD/MD degree required. Minimum 2 to 4 years in industry application of clinical medicine/pharmacy with a minimum of 1 year in pharmaceutical drug safety. Experience in verbally interviewing and/or providing medical information to health care professionals and consumers. Application of clinical medicine to patient care. Medical terminology and standards of patient care. Computer proficiency.