Advertisement
Mitocon Biopharma, a trusted name in drug safety and regulatory services, is hiring Associate (DSA I/II) professionals for its Hyderabad (Begumpet) office. This full-time, in-office role offers an excellent opportunity for pharma graduates with 2–6 years of experience in aggregate report preparation and signal management.
If you have hands-on experience in PADERs, PSURs, PBRERs, DSURs, and RMPs, this role could be the ideal next step in your pharmacovigilance career.
Key Responsibilities
- Prepare and review aggregate safety reports including DSURs, IND Annual Reports, PADERs, PSURs, and PBRERs.
- Conduct quality reviews of all aggregate reports to ensure compliance with regulatory guidelines.
- Perform signal detection and data mining using manual signal detection methods.
- Draft Signal Management Reports (SMRs) for safety signal tracking.
- Support Quality Assurance documentation and complete required training activities.
- Collaborate with cross-functional teams to maintain pharmacovigilance process integrity.
Required Qualifications
- Education: B.Pharm, M.Pharm, or Pharm.D.
- Experience: 2–6 years in Pharmacovigilance, specifically in Aggregate Reports.
- Skills: Strong understanding of global safety reporting formats (PADERs, PSURs, RMPs, PBRERs).
- Notice Period: 30 to 60 days.
- Location: On-site, Begumpet – Hyderabad.
Why Join Mitocon Biopharma?
- Work with experienced safety scientists on international pharmacovigilance projects.
- Exposure to cutting-edge drug safety processes.
- Competitive salary and growth-oriented environment.
- A collaborative and innovation-driven workplace culture.
How to Apply
Interested candidates can send their details to hr@mitoconbiopharma.com
with the subject line “Aggregate Reports – Application”.
Advertisement
Please include:
- Total and relevant experience
- Reason for job change
- Notice period
- Current and expected CTC
- Current location and organization
- Educational qualification
📞 HR Contact: Keerthi Boga – AM-HR
📱 +91 91543 83165
Advertisement
