Qualification: M. Pharm / B. Pharm / BAMS / BHMS / BDS (Health care professional)

Location: Mumbai

Experience:

• 2 to 3 years of experience in drafting and reviewing of PADER, PSUR, PBRER and RMP.

Job Responsibilities:

• Preparation and quality review of various types of Aggregate Reports (AR)-PSUR, PBRER, Annual Safety Report, PADER, RMP, etc.
• Strategizing for submission of ARs.
• Kick-off meeting arrangement with clients, and relevant stakeholders (ICSR team, etc.)
• Generate line listings and summary tabulations, referring to the processed ICSR for ARs and XML from a global safety database.
• Issue Identification and resolution.
• Support in other departmental activities.

Qualification: B Pharm, M Pharm, BHMS, BAMS

Location: Navi Mumbai

Experience:

• 2 to 4 years in safety writing & aggregate reports

Job Responsibilities:

• Checking the arrival of source documents and final signed off copies of aggregate reports.
• Keeping check on the online aggregate report tracker.
• To help with analysis of action items populated in nonconformance.

Qualification: B Pharm / M Pharm

Job Profile: Reconciliatio, and Compliance Monitoring Activities

Location: Navi Mumbai

Experience:

• 5-8 years in Pharmacovigilance domain.
• Proficiency in MS-excel and mailbox management.

Job Responsibilities:

• Management of various safety reconciliation and compliance monitoring activities for clients.
• Reconciliation of reference safety Information for client’s products.
• Data mining and review of FDA's Adverse Event Reporting System (FAERS) and other regulatory databases.
• Edit, Review, and Reconciliation of Consolidated Global Product List.
• Management of global Exchange of Safety information for product approvals/ launches / cancellations / and RSI updates - Global
• Maintaining and updating documents relevant to safety reconciliation.

Qualification: B. Pharm / M Pharm / BAMS / BHMS

Location: Navi Mumbai

Experience:

• 2-4 years of experience in a pharmaceutical company in the management of training-related activities

Job Responsibilities:

• Managing Pharmacovigilance and non-Pharmacovigilance training to employees, subsidiaries, partners, and vendors globally.
• Manage e-learning systems and portals.
• Track compliance on training.
• Perform cyclical review of training related documents and files.
• Manage training related documentation.
• Actively contribute to the development of processes, applications, and methodologies in the department.
• Perform Impact analysis for PV training compliance strategies, development of procedural documents and working practices, Including Inputs Into SOPs, Wis, WPS, and other pertinent processes.