Pharmazone is a leading global provider of regulatory and pharmacovigilance services, committed to delivering high-quality solutions to the pharmaceutical industry. With a strong reputation for excellence, innovation, and compliance, we help organizations navigate complex regulatory landscapes while ensuring patient safety. Our expertise spans across medical writing, aggregate reporting, risk management, and literature monitoring.
Job Responsibilities
As an Aggregate Report Specialist at Pharmazone, you will play a crucial role in pharmacovigilance and medical writing. Your key responsibilities include:
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- Authoring Aggregate Reports: Preparing PSURs/PBRERs, PADERs, Annual Reports, ACOs, and DSURs for submission to local and global health authorities.
- Risk Management Plan (RMP) Authoring: Creating comprehensive RMPs as part of ongoing pharmacovigilance activities.
- Signal Management Reporting: Conducting signal management activities and preparing reports to ensure compliance.
- Literature Search & Validity Checks: Performing thorough literature searches and assessing data validity for accurate report preparation.
- Data Extraction & Validation: Extracting and validating data, including RSI, sales figures, previous reports, RMPs, and signals.
- Line Listing Generation: Generating Line Listings (LL) from safety databases for accurate reporting.
- Tracker Reconciliation: Ensuring proper reconciliation of relevant process trackers.
- Support for High-Priority Activities: Providing reliable assistance for high-priority, ad-hoc pharmacovigilance tasks.
- Timely Report Drafting: Ensuring all reports are completed within the allocated timelines with accuracy and efficiency.
Qualifications & Experience
To be eligible for this role, candidates should possess:
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- A Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
- 2 to 4 years of experience in pharmacovigilance and medical writing.
- Strong expertise in PSURs, PADERs, RMPs, DSURs, and aggregate reporting.
- In-depth knowledge of regulatory requirements and pharmacovigilance guidelines.
- Experience in literature searches and signal management reporting.
Required Skills
Candidates must demonstrate proficiency in the following skills:
- Medical writing and pharmacovigilance documentation.
- Aggregate report authoring (PSURs, PADERs, DSURs, etc.).
- Strong analytical and problem-solving skills.
- Attention to detail and ability to validate large datasets.
- Excellent communication and technical writing skills.
- Proficiency in using safety databases and regulatory tools.
- Time management and ability to meet deadlines.
