The Pharmacovigilance (PV) department in the pharmaceutical industry plays a crucial role in ensuring the safety and efficacy of pharmaceutical products, particularly in monitoring, assessing, and preventing adverse drug reactions (ADRs). Its primary focus is on the detection, evaluation, understanding, and prevention of adverse effects or any other drug-related problems once the product is on the market.
Key Responsibilities of Pharmacovigilance:
1. Monitoring Drug Safety: Collecting and assessing data related to the safety of medicines from clinical trials and post-marketing surveillance.
2. Adverse Event Reporting: Reporting adverse drug reactions (ADRs) to health authorities (e.g., FDA, EMA) in compliance with regulatory requirements.
3. Signal Detection: Identifying new risks or changes in known risks associated with a drug through data analysis and scientific evaluation.
4. Risk Management: Developing risk management plans (RMPs) to minimize the risk of ADRs and ensure the safe use of the product.
5. Case Processing: Receiving, documenting, and assessing individual case safety reports (ICSRs) related to ADRs from healthcare professionals and consumers.
6. Periodic Safety Updates: Preparing periodic safety update reports (PSURs) or periodic benefit-risk evaluation reports (PBRERs) that summarize the safety profile of a drug over time.
7. Regulatory Compliance: Ensuring that the pharmaceutical company complies with global pharmacovigilance regulations and guidelines.
8. Audits and Inspections: Preparing for pharmacovigilance audits and inspections by regulatory authorities to ensure that the company’s processes and systems meet regulatory standards.
9. Risk-Benefit Analysis: Continually evaluating the balance of benefits and risks for the product, based on emerging safety data.
10. Collaboration: Working closely with regulatory affairs, clinical research, and medical affairs departments to ensure a holistic approach to drug safety.
Pharmacovigilance is critical to maintaining public health and trust in pharmaceuticals, helping companies mitigate risks while providing essential data to ensure the safety of the patients using their products.
Hiring Immediate Joiners only (F2F Interview) :
Hiring Pharmacovigilance (PV) Specialists with 1-3 years of experience (Immediate joiners)
Location : Hyderabad
Key Skills:
ICSR Case possessing, Literature Review Argus Safety Database, Post Marketing Surveillance, Eudravigilance, XML Handling
A new-age clinical services client in Hyderabad hiring PV specialists. Their spectrum of services includes Clinical Trial Safety Operations, Pharmacovigilance, Regulatory Affairs, Biostatistics and Clinical SAS Programming, etc.
Please share your resume to: Careers@thereqrootr.com
