Dhara Naik

1. To perform literature string setup and review literature

article from PubMed and performed validation of ICSR,

maintained record, and perform reconciliation weekly

for compliance.

2. Diligently monitor and maintain up-to-date

pharmacovigilance records across various regulatory

platforms, including the European Medicines Agency

(EMA), Medicines and Healthcare products Regulatory

Agency (MHRA), and Medical Literature Monitoring

(MLM) ensuring adherence to meet pharmacovigilance

requirements

3. Conduct thorough assessments of ICSR and other

safety information derived from clinical trials, post-

marketing surveillance, spontaneous reports, and

literature article.

4. Formulate and update Risk Management Plans in

alignment with European Union (EU) regulatory

standards, encompassing the identification,

assessment, and mitigation of risks associated with

medicinal products to ensure patient safety and

compliance.

5. Lead the preparation, revision, and review of SOPs,

Work Instructions (WIs), templates, and guidance

documents. Develop and deliver training materials to

ensure consistent understanding and application of

pharmacovigilance processes across teams.

6. Ensure that Medical enquiry e-mail box, phone and

postage are checked daily for adverse events/Medical

enquiry/Product enquiry/Product Quality complaint,

and tracking and kept record of inquiries in accordance

with company's controlled documents.

7. Reconcile and acknowledge adverse events/product

complaints emails in accordance with safety data

exchange as per SDEA.

8. Assist leadership in achieving compliance during

internal and client audits. Provide detailed responses

and implement corrective and preventive actions

(CAPAs) to address identified gaps in pharmacovigilance

processes.

1. Data Entry of ICSRs in Pharmacovigilance database.

Entering source data in the database, Coding,

Narrative(s) writing and Generate Follow-up letters

2. Book in and Triaging of ICSRs

3. Review of literature articles and assessment for

identifying valid ICSRs.

4. Quality Check of ICSRs in database.

5. Compliance to project guidelines

6. Execution of Company Standard Operating Procedures

7. Builds and maintains good relationships across

functional units and company affiliates

8. Maintain awareness of changes to/new regulations

affecting PVG activities

9. To carry out necessary administrative duties required

for the job

Medical Enquiry Handling

1. Ensure that Medical enquiry e-mail box, fax machine,

phone and postage are checked daily for adverse

events/Medical enquiry/Product enquiry/Product

Quality complaint.

2. Tracking and Handling of medical enquiry in

accordance with company's controlled documents (e.g.

SOPs, Wls, Guide).

3. Logging and updation of enquiry in Medical Information

database

4. Preparation and communication of enquiry response in

liaise with designated medical reviewer.

5. Assist designated medical reviewer for follow up of all

medical enquiry.

6. Reconciliation of medical enquiries received from

clients and their affiliates, business partners.

7. Reconcile and acknowledge adverse events/product

complaints emails in accordance with safety data

exchange as per SDEA and PMP.

Additional Responsibilities

• Preparation, revision, reviews of SOPs, Wls, templates,
• guide and guidance training documents.
• Communication of urgent safety issues to Line manager and QPPV.
• Ensure communication with all relevant people is of a high professional standard, and that records of both internal and external communication are maintained.
• Ensuring compliance (quality, procedures, regulations, timeliness, consistency) with local regulations and Company's global Pharmacovigilance requirements.
• Deliver training to new joinee and team as per requirement.
• Work with the Aggregate report/ ICSR team/Medical review team leader to escalate issues or tasks outside the normal scope of work.
• Support group leader for timely submission of ICSR in order to achieve 100% regulatory compliance.

· Teaching of Pharmacology to B.Pharm and M.Pharm Students

· Conducting practicals for B.Pharm and M. Pharm Students.

Arranging CPCSEA meetings, Co-ordinator for PCI affiliation, Co-ordination of co- curricular activities of college