ProPharma is inviting applications for the position of PV – Aggregate Report Writer in Hyderabad, India. This is an excellent opportunity for experienced pharmacovigilance professionals with expertise in aggregate report writing, benefit-risk evaluation, medical writing, signal management, literature review, and regulatory pharmacovigilance. Candidates with strong experience in PSUR, PBRER, DSUR, PADER, RMP, and signal detection are encouraged to apply.
If you have a solid background in pharmacovigilance medical writing and are looking to work with a global regulatory consulting organization, this ProPharma career opportunity could be your next move.
Job Details
| Particular | Details |
|---|---|
| Position | PV – Aggregate Report Writer |
| Company | ProPharma |
| Job Type | Full Time |
| Work Mode | Office Based (Hybrid encouraged) |
| Location | Hyderabad, India |
| Department | Pharmacovigilance โ Benefit Risk |
| Experience | 6+ Years |
| Qualification | Bachelor’s or Master’s in Pharmacy, Nursing, Life Sciences, or related healthcare discipline |
About ProPharma
For over 25 years, ProPharma has supported biotechnology, pharmaceutical, and medical device companies worldwide by delivering expert services across regulatory affairs, clinical research, pharmacovigilance, medical information, quality & compliance, and R&D technology. The company partners with clients throughout the product lifecycle to accelerate the development and commercialization of innovative therapies.
Key Responsibilities
The selected candidate will be responsible for:
- Authoring Aggregate Safety Reports including:
- PSUR
- PBRER
- PADER
- Annual Reports
- ACO
- DSUR
- Preparing Risk Management Plans (RMPs)
- Writing Signal Management Reports
- Performing literature searches and literature validity assessments
- Extracting and validating safety data, RSI, sales data, previous reports, and signal information
- Generating line listings from safety databases
- Reconciling pharmacovigilance process trackers
- Supporting urgent pharmacovigilance deliverables
- Ensuring compliance with global regulatory timelines
- Collaborating with senior PV scientists and benefit-risk teams
- Supporting SOP, Work Instruction (WI), CAPA, and deviation documentation
Required Qualifications
Applicants should possess:
- Bachelor’s or Master’s degree in:
- B.Pharm
- M.Pharm
- Nursing
- Life Sciences
- Other healthcare-related disciplines
- Equivalent industry experience may also be considered.
Required Experience
Candidates should have:
- Minimum 6 years of Pharmacovigilance experience
- Strong experience in:
- Aggregate Report Writing
- Medical Writing
- Literature Search
- Signal Detection
- Experience authoring and reviewing aggregate reports
- Experience participating in quality discussions and client interactions
- Knowledge of pharmacovigilance metrics and compliance activities
Preferred Skills
Successful candidates should demonstrate:
- Strong analytical and scientific writing skills
- Excellent medical writing capabilities
- Knowledge of:
- ICH Guidelines
- GCP
- FDA Regulations
- EMA Guidelines
- Global Pharmacovigilance Regulations
- Experience with benefit-risk evaluation
- Attention to detail and quality-focused mindset
- MS Office proficiency
- Ability to work in global cross-functional teams
- Experience with safety databases and line listing generation
- Knowledge of SOPs, CAPA, deviations, and quality systems
Why Join ProPharma?
Working at ProPharma offers:
- Opportunity to work on global pharmacovigilance programs
- Exposure to international regulatory submissions
- Career growth in Benefit-Risk and Aggregate Report Writing
- Collaborative global teams
- Inclusive and diverse workplace
- Hybrid working opportunities (where applicable)
- Learning and development opportunities
- Direct application review by recruitment specialists without AI screening
How to Apply
