Product Safety Specialist

vmysmartpros; India; On-site; INR 600,000 - 1,200,000; Full time

Job summary

vmysmartpros in India is seeking a Pharmacovigilance Specialist responsible for receiving and documenting safety reports for marketed and investigational products. You will interact with health professionals and consumers to collect adverse event information and provide medical information to healthcare providers, consumers, and sales teams.

You will code and enter data into the global safety database, ensure accurate case records, and support regulatory reporting to FDA-aligned authorities and

Qualifications

• Bachelor’s degree in medical field required; RN/RPh licensure or PharmD/MD preferred.
• Experience in industry pharmacovigilance with understanding of clinical medicine.
• Experience in communicating medical information to health professionals and consumers.

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 adverse events.
• Provides product information to health providers, consumers, and sales representatives.

Skills

Pharmacovigilance

Medical information

Data entry

ARISg

MedDRA coding

Regulatory reporting

Education

Bachelor's degree in medical field

RN or RPh licensure or PharmD/MD

Tools

ARISg

MS Office

Job description

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 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 each 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 timely data entry of both domestic and foreign adverse event and serious adverse event information into the PSSS (Product Safety Surveillance System) consistent with the ARISg coding manual, SOPs/WIDs, process flows and established time frames within the ARISg workflow. Full understanding of the company’s core data sheet, PI, and/or IB for accurate labeling and listing. Perform appropriate and timely follow‑up per department guidelines, including accurate and thorough communication documentation within 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 timely submissions to regulators, co‑marketing partners and affiliates within company and regulatory timeframes. Utilize ARISg for all reporting and confirmation of successful distribution and acknowledgement.

Maintain sufficient knowledge of all company products to ensure professional and knowledgeable discussions with consumers and health‑care providers and dissemination of accurate product information in response to queries. Provide high‑level customer service to consumers, health‑care professionals and internal customers.

Complete all required training within the timelines provided so as to ensure knowledge of all relevant corporate and departmental SOPs, SWPs and WIDs.

Gather sufficient information to assess the medical significance of an adverse event report, while at the same time assuring the information provided adequately addresses the concerns of the health‑care provider and/or consumer.

Required Qualifications & Skills

• Bachelor’s 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.