Merck Group: PV Scientist – Senior Expert – MD/PhD Candidates Apply Now!
Join Merck Group, a global leader in Healthcare, Life Science, and Electronics, as a PV Scientist – Senior Expert in Bangalore. Suppose you have 4+ years of experience in Pharmacovigilance risk management and expertise in clinical development and post-marketing safety. In that case, this is your chance to work on safety signal detection, risk management plans, and clinical trial activities. Apply now and be part of a team driving innovation in patient safety and regulatory compliance!
Title: PV Scientist – Senior Expert
Location: Bangalore, India
Purpose of the Role:
As a PV Scientist – Senior Expert, you will play a pivotal role in pharmacovigilance activities, ensuring the safety of our products and contributing to patient well-being.
Your Role:
- Signal Detection and Management:
- Perform safety monitoring using tools like Spotfire, EVDAS, and Empirica Signals.
- Review and analyze clinical and safety database outputs.
- Interpret aggregate safety data from clinical trials and post-marketing sources.
- Review scientific literature for safety surveillance.
- Support safety signal analyses and contribute to evaluation reports.
- Participate in safety governance meetings.
- Support communication of Emerging Safety Issue Reports.
- RMP Updates and Periodic Safety Reports:
- Retrieve and summarize data for Risk Management Plans (RMPs) and periodic safety reports.
- Support local adaptation of RMPs and respond to health authority questions.
- Submissions and Safety Variations:
- Contribute to safety-relevant documents for Common Technical Document (CTD).
- Contribute to ISS/SCS IAP, health authority briefing documents, and product information.
- Clinical Trial Activities:
- Provide input on safety sections of IMPD, IB, and ICF.
- Support safety-related input for clinical trial documents.
- Provide safety-related input for data monitoring committees.
- Other Activities:
- Respond to auditor/inspector queries.
- Contribute to post-authorization safety studies.
- Develop and maintain MedDRA CMQs.
- Create product-specific training.
- Provide expert input on process standardization.
Who You Are:
- Qualification:
- MD, or PhD/advanced science degree in a biomedical/health-related field.
- Fluent in written and spoken English.
- Experience:
- Over 4 years of Pharmaceutical industry experience or similar.
- Experience in Pharmacovigilance risk management.
- Experience with submissions.
- Ability to work in a global team.
- Tech-savvy with strong analytical and communication skills.
What We Offer:
- A diverse and inclusive work environment.
- Opportunities for professional growth and development.
- A culture of innovation and collaboration.
- Equal opportunity employment.
Keywords:PV Scientist, Senior Expert, Bangalore, Pharmacovigilance, Risk Management, Clinical Trials, Safety Signals, Pharmaceutical Jobs, Drug Safety, Medical Affairs, Regulatory Affairs, Life Sciences Jobs, Merck Group.
