COD Research has announced an opening for an Aggregate Report Writer in its Patient Safety department in Ahmedabad. This opportunity is suitable for pharmacovigilance professionals with 1–6 years of experience in Aggregate Reporting or Medical Safety.
The role involves the preparation, updating and quality review of key pharmacovigilance aggregate safety reports, including PSUR, PBRER and DSUR, along with literature surveillance, signal detection support, regulatory intelligence and compliance activities.
Candidates with a Life Science Graduate/Post-Graduate qualification, including B.Pharm and M.Pharm, and relevant aggregate reporting experience can apply.
COD Research Aggregate Report Writer – Job Overview
| Particulars | Details |
|---|---|
| Company | COD Research |
| Position | Aggregate Report Writer |
| Department | Patient Safety |
| Location | Ahmedabad, Gujarat |
| Employment Type | Full-Time, Permanent |
| Experience | 1–6 Years |
| Qualification | Life Science Graduate/Post-Graduate |
| Preferred Degrees | B.Pharm / M.Pharm |
| Industry | Clinical Research / Contract Research |
| Key Skills | PSUR, PBRER, DSUR, Aggregate Reporting, Medical Safety |
| Openings | 1 |
| Salary | Not disclosed by employer |
About the Aggregate Report Writer Role
As an Aggregate Report Writer at COD Research, the selected candidate will support pharmacovigilance and patient safety activities by preparing and reviewing periodic aggregate safety reports.
The position requires practical knowledge of PSURs (Periodic Safety Update Reports), PBRERs (Periodic Benefit-Risk Evaluation Reports) and DSURs (Development Safety Update Reports). The professional will also work with safety databases, literature sources, regulatory intelligence and internal or external pharmacovigilance stakeholders.
This role may be particularly relevant for candidates seeking to develop their careers in aggregate reporting, drug safety, pharmacovigilance and medical safety writing.
Key Responsibilities
The Aggregate Report Writer will be responsible for:
- Preparing, updating and performing quality reviews of PSURs, DSURs, PBRERs and other aggregate safety documents.
- Generating applicable line listings from pharmacovigilance or safety databases.
- Conducting literature screening to identify information relevant to aggregate reports.
- Performing literature searches supporting aggregate reporting and signal detection activities.
- Reviewing and identifying relevant case reports and Areas of Interest (AOIs) from literature and regulatory sources.
- Monitoring regulatory developments and maintaining awareness of new or updated regulations affecting pharmacovigilance.
- Providing input for regulatory actions arising from emerging safety concerns, including variations, urgent safety restrictions and safety communications.
- Coordinating with sponsors, clients, medical monitors and pharmacovigilance physicians when additional information or actions are required.
- Supporting audits and regulatory inspections in collaboration with Quality Assurance teams.
- Preparing and reviewing SOPs, Work Instructions, guides and training materials.
- Providing quality, compliance and supporting documentation required for pharmacovigilance oversight.
- Screening regulatory intelligence sources to identify changes affecting pharmacovigilance processes.
- Communicating applicable regulatory changes to management and relevant Patient Safety team members.
Qualification & Eligibility
Candidates interested in the COD Research Aggregate Report Writer job in Ahmedabad should meet the following requirements:
Educational Qualification:
Life Science Graduate or Post-Graduate candidates are eligible. The job listing specifically mentions:
- B.Pharm
- M.Pharm
- Other relevant Life Science Graduate/Post-Graduate qualifications
Experience Required:
Candidates should have 1–6 years of relevant experience in Aggregate Reports and/or Medical Safety.
This is therefore not primarily a fresher position. Applicants should ideally have hands-on exposure to pharmacovigilance aggregate reporting activities.
Key Skills Required
Candidates with experience in the following areas will be particularly relevant:
Aggregate Reporting | PSUR | PBRER | DSUR | Pharmacovigilance | Drug Safety | Medical Safety | Literature Screening | Signal Detection | Safety Database | Regulatory Intelligence | SOP Preparation | Quality Review | Patient Safety
Experience preparing or reviewing PSUR/PBRER/DSUR reports would closely align with the responsibilities specified in the job description.
Why Consider This Opportunity?
The COD Research Aggregate Report Writer role provides exposure to several important areas of pharmacovigilance beyond routine case processing. Based on the published responsibilities, the role includes opportunities to work with:
- Multiple types of aggregate safety reports
- Literature surveillance and safety information
- Signal detection support
- Regulatory intelligence
- Safety-related regulatory actions
- Audit and inspection support
- SOP and controlled-document preparation
- Sponsor/client and medical stakeholder communication
These responsibilities can help professionals build broader expertise within aggregate reporting and pharmacovigilance compliance.
Who Should Apply?
This opening may be particularly relevant for candidates currently working as an:
Aggregate Report Writer, Pharmacovigilance Associate, Drug Safety Associate, Medical Safety Associate, Aggregate Reporting Associate, Safety Writer or PV Specialist with relevant PSUR/PBRER/DSUR experience.
Candidates should review their experience against the official job requirements before applying.
How to Apply
