A leading pharmaceutical organization in Sanathnagar, Hyderabad, is currently hiring for the position of Assistant Manager/Deputy Manager – Pharmacovigilance. The company is committed to ensuring drug safety and compliance with global regulatory standards. With a strong focus on patient well-being and high-quality healthcare solutions, it offers an excellent work environment for experienced pharmacovigilance professionals.
Job Responsibilities
As an Assistant Manager/Deputy Manager in Pharmacovigilance, the selected candidate will be responsible for:
- Leading the aggregate reporting team to ensure regulatory compliance in preparing, reviewing, and submitting aggregate reports, including PADERs, PBRERs/PSURs, Signal Reports, and Risk Management Plan Reports.
- Overseeing the assignment of activities within the team to maintain efficient workflow and ensure timely delivery of high-quality aggregate reports.
- Ensuring all pharmacovigilance tasks are performed in adherence to applicable Standard Operating Procedures (SOPs) and Work Instructions (WIs).
- Providing responses to regulatory queries related to safety topics and supporting the development of safety documents.
Qualifications
Candidates must possess the following educational qualifications:
- M. Pharmacy (Master of Pharmacy) or Pharm D (Doctor of Pharmacy)
- Minimum of 8-10 years of experience in handling pharmacovigilance aggregate reports, including PBRERs/PSURs, PADERs, RMP, and Signal Management Reports.
Required Skills
To be successful in this role, candidates should have:
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- Expertise in Pharmacovigilance Aggregate Reporting (PADERs, PBRERs/PSURs, Risk Management Plans, and Signal Reports)
- Strong understanding of regulatory requirements and compliance guidelines
- Experience in leading a team and assigning tasks efficiently
- Ability to work within SOPs and Work Instructions
- Excellent communication and regulatory query handling skills
- Strong analytical and problem-solving skills
