The Associate Safety Case Reviewer role is an on-site opportunity in Pune, Maharashtra, within the Medical Writing function. The position supports pharmacovigilance and clinical research activities, including adverse event analysis and processing, safety reporting, data integrity, and compliance with applicable guidelines, SOPs, and client requirements.
Job Details
| Job Detail | Information |
|---|---|
| Position | Associate Safety Case Reviewer |
| Job Type | Full-time, Permanent |
| Work Mode | On-site |
| Location | Pune, Maharashtra, India |
| Department/Function | Medical Writing |
Position: Associate Safety Case Reviewer
The Associate Safety Case Reviewer collaborates with the Pharmacovigilance Solutions Production team to analyze and report safety parameters related to patient safety and client products, while following client requirements for case review.
Responsibilities
- Perform adverse event analysis and processing in support of clients’ clinical research.
- Prepare safety reports for submission to various health authorities.
- Maintain data integrity and support audit compliance by following Good Documentation Practice (GDP) standards.
- Adhere to project timelines and proactively communicate with Team Leads and Project Managers when required.
- Follow applicable conventions, governing-body requirements, divisional guidelines, templates, and Standard Operating Procedures (SOPs).
- Analyze stakeholder complaints related to safety reporting and address them in real time.
- Discuss safety reporting concerns with Project Managers to mitigate risks and implement or drive solutions.
- Complete other tasks appropriate to the role as assigned by the manager or supervisor.
Required Skills
Candidates should have:
- Knowledge of Common Toxicity Criteria (CTC) and/or MedDRA coding.
- Knowledge of Good Clinical Practice (GCP).
- Knowledge of Good Documentation Practice (GDP).
- Knowledge of International Conference on Harmonization (ICH) guidelines.
- Proficiency in:
- Microsoft Word
- PowerPoint
- Excel
- Outlook
- EndNote
- Familiarity with scientific databases such as PubMed and Embase.
- Excellent written and oral communication skills in English.
- Ability to work effectively in collaborative, cross-functional teams.
- Strong attention to detail when reviewing and validating work.
- Ability to ensure compliance with SOPs and client specifications.
