ProPharma Group India is a leading global provider of regulatory, clinical, and compliance services to the pharmaceutical, biotechnology, and medical device industries. With a commitment to quality and patient safety, ProPharma Group offers innovative solutions to help companies achieve regulatory compliance and streamline drug development processes. The company fosters a collaborative work environment and provides extensive training opportunities to its employees.
Responsibilities in Job As a Pharmacovigilance Specialist at ProPharma Group India, you will be responsible for ensuring compliance with global regulatory requirements and maintaining high-quality pharmacovigilance (PV) operations. Key responsibilities include:
- Monitoring incoming reports from multiple sources such as mailboxes, EudraVigilance, and literature searches.
- Downloading and processing L2A (Regulatory Authority) and MLM cases from EV Web using client-specific filters.
- Conducting triage of incoming reports for completeness, duplicate check, legibility, and validity.
- Performing literature searches based on predefined search strategies.
- Coding medical history, adverse events, drugs/procedures, indications, and laboratory tests using MedDRA, Company Product Dictionary, and WHO-DD.
- Writing medically relevant safety narratives and ensuring the accuracy of data entered in various fields.
- Maintaining process-specific trackers for efficient workflow management.
- Ensuring compliance with internal and regulatory timelines for adverse event reporting.
- Assessing expectedness, causality, and seriousness criteria for reported events.
- Managing follow-up requests and query handling as needed.
- Attending internal, drug safety, and project-specific training sessions.
- Completing training assignments on internal and client Learning Management Systems (LMS) within designated deadlines.
Qualifications To be eligible for the Pharmacovigilance Specialist role at ProPharma Group India, candidates must meet the following qualifications:
- A bachelor’s or master’s degree in Pharmacy, Life Sciences, or a related field.
- 2 to 4 years of experience in pharmacovigilance.
- Strong knowledge of MedDRA and case processing.
- Familiarity with regulatory reporting obligations and industry guidelines.
Skills Required The ideal candidate should possess the following skills:
- Proficiency in adverse event case processing and safety database management.
- Ability to conduct literature searches and apply relevant search strategies.
- Excellent medical coding skills using MedDRA and WHO-DD.
- Strong analytical skills for triaging reports and assessing case validity.
- Effective written and verbal communication skills.
- Attention to detail and high accuracy in data entry.
- Ability to work independently and within a team environment.
- Proficiency in MS Office applications and pharmacovigilance software.
