job title: senior associate pv (advity)

Qualifications:

• B.Pharmacy / M.Pharmacy / Pharm.D

Preferred Skills:

• Minimum of 3-4 years of experience in pharmacovigilance including ICSR (from literature sources) and aggregate reports.

• Extensive knowledge of medical terminology, clinical pharmacology, patent treatment, diagnostic investigations and pathology.

• Sound knowledge of pharmacovigilance principles and international regulatory requirements related to drug and patient safety.

• Possess excellent communications skills with professional English speaking, writing, presenting skills and must be detailed oriented.

• Excellent organizational and time management skills.

• Ability to work effectively independently and within a team environment and across global teams. 

Detailed Responsibilities:

• Case processing (solicited and unsolicited reports) for drugs, devices, vaccines, biologic product and cosmetics.

• QC review of Literature search and Individual Case Safety Reports (ICSRs) activities.

• Reporting ICSRs and submission of all PV, CT deliverables to client/Regulatory authorities.

• Maintenance of ICSR, Literature search and other related trackers.

• Perform periodic and regular reconciliation with clients.

• Provide queries relating to additional information required for processing ICSRs and share to MICC team to perform follow up activities with HCP/Customer/Patients.

• Handling/supporting PV meetings, client calls, MOM drafting etc.

• Preparation or support preparation of safety processes and procedures (SOPs/Work instructions).

• Perform reconciliation with clients.

• Monitoring Health authority websites for latest updates.

• Training other Pharmacovigilance team associates on relevant company procedures, latest Regulations and Guidelines.

• Compliance with related SOP/procedures on quality and timely submission of PV deliverables.

• Compliance with Pharmacovigilance Regulations and Guidelines.