ProPharma Group is a premier global consulting partner for the biotech, pharmaceutical, and medical device industries. For over two decades, they have been at the forefront of helping healthcare innovators navigate the complex journey from development to market. Their end-to-end services encompass regulatory sciences, clinical research, pharmacovigilance, medical information, and R&D technology.
Trusted by everyone from ambitious startups to Fortune 500 companies, ProPharma’s mission is to improve patient health and wellness worldwide by ensuring therapies are brought to market safely and effectively. Joining their team means becoming part of a culture that values expertise, innovation, and a shared commitment to global patient safety.
Job Description: Pharmacovigilance Specialist – Case Processing
As a Pharmacovigilance Specialist, you will be at the heart of ProPharma’s drug safety operations. Your primary responsibility will be the end-to-end management of Individual Case Safety Reports (ICSRs), ensuring the highest standards of accuracy and regulatory compliance.
Key Responsibilities:
- Process and manage Individual Case Safety Reports (ICSRs) from receipt to submission.
- Perform triage and initial assessment of cases for seriousness, expectedness, and causality.
- Accurately code adverse events, medical history, and drugs using standardized medical terminologies like MedDRA and WHO-DD.
- Write and review clear, concise, and accurate medical narratives for safety reports.
- Generate follow-up queries to obtain missing or unclear information for case completion.
- Ensure timely expedited reporting of cases to global health authorities (e.g., FDA, EMA) in accordance with regulatory guidelines.
- Prepare and review submissions for regulatory compliance.
- Perform quality review (peer QC) of cases processed by other team members.
- Contribute to the development and updating of Standard Operating Procedures (SOPs) and working practices.
- Stay updated on evolving global pharmacovigilance regulations and guidelines.
Eligibility & Qualifications
Education:
- Mandatory: Bachelor’s degree in Life Sciences (Pharmacy, Biotechnology, Biochemistry, Microbiology, Nursing, or a related field).
- Preferred: Advanced degree such as M.Sc, Pharm.D, BDS, RPh, or RN.
Experience:
- A minimum of 2 years of experience in pharmacovigilance, specifically in case processing (ICSR management) is required.
Required Skills:
- Strong foundational knowledge of pharmacovigilance principles and global safety regulations.
- Hands-on experience with MedDRA coding.
- Excellent medical writing skills with high attention to detail.
- Strong analytical and problem-solving abilities.
- Ability to work effectively both independently and within cross-functional teams.
- Superior written and verbal communication skills.
Job Details
- Role: Pharmacovigilance Specialist – Case Processing
- Industry Type: Pharma / Biotech / Clinical Research
- Employment Type: Full Time, Permanent
- Location: Bangalore, India
- Salary: A competitive salary package commensurate with experience and industry standards.
How to Apply for ProPharma Group Pharmacovigilance Jobs
Interested and eligible candidates can apply for this pharmacovigilance job in Bangalore through the official ProPharma Group career portal.
