Are you a pharmacovigilance professional looking for a rewarding career in Ahmedabad? COD Research, a leading name in clinical research, is hiring a Medical Safety Executive to join their Patient Safety Department. With a focus on preparing safety documents, mentoring teams, and ensuring regulatory compliance, this role offers an exciting opportunity for professionals with 2-5 years of experience in pharmacovigilance or materiovigilance. If you’re passionate about patient safety and clinical research, this full-time, permanent position in Ahmedabad is your chance to make a difference.
Key Responsibilities
As a Medical Safety Executive at COD Research, you will play a critical role in ensuring patient safety and regulatory compliance. Your responsibilities will include:
- Preparing and updating aggregate safety reports such as PADERs, PSURs, DSURs, RMPs, PBRERs, REMS, and signal management documents.
- Generating line listings from safety databases and conducting literature screening for case reports and Areas of Interest (AOIs).
- Creating and maintaining Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post Market Clinical Follow Up Plans (PMCFP), PMCF Reports, and Summary of Safety and Clinical Performance (SSCP) for medical devices per EU MDR 2017/745 and MEDDEV 2.7/1 Rev 4.
- Maintaining Post-Market Surveillance (PMS) documents and risk management files for medical devices and combination products.
- Training and mentoring new and existing employees on pharmacovigilance activities and aggregate report writing.
- Retrieving data from safety databases and EDC systems to generate validated ad-hoc and periodic reports.
- Collaborating with internal and external stakeholders, including sponsors, clients, and medical monitors, to address safety concerns and provide complete narratives.
- Conducting follow-ups with reporters (e.g., clinical study teams, healthcare professionals, or patients) for clarification and missing case details.
- Performing medical, drug, and device term coding per applicable coding dictionaries and guidelines.
- Maintaining project-specific folders, participating in audits, and preparing SOPs, WIs, and training materials.
- Ensuring compliance with ICH, GVP, MDR, and US regulations.
Qualifications and Experience
To excel in this role, candidates should meet the following requirements:
- Education: A scientific degree is required; an advanced degree (M.Pharm, PharmD, or PhD) is preferred.
- Experience: 2-5 years of experience in pharmacovigilance and/or materiovigilance, with familiarity in medical terminology.
- Industry Knowledge: Experience working with biopharmaceutical or medical device companies in the EU/US regions, particularly with vaccines, cell and gene therapies, or medical devices.
- Regulatory Expertise: Strong understanding of ICH, GVP, MDR, and US regulations.
- Skills: Proficiency in safety database management, report generation, and stakeholder communication.
Benefits of Joining COD Research
- Career Growth: Work with a reputed clinical research organization and gain exposure to diverse product types, including vaccines and medical devices.
- Professional Development: Opportunities to train and mentor colleagues, contributing to team success.
- Impactful Work: Play a key role in ensuring patient safety and regulatory compliance in clinical research.
- Stable Employment: Enjoy a full-time, permanent position in Ahmedabad, a hub for clinical research.
How to Apply
