Senior Associate PV (ICSR)
Location: Hyderabad
Experience: 03-04 Years
Qualifications & Other Specifics
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.
