Senior Associate PV (Aggregate)

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:

• Manage the preparation of aggregate safety reports such as PSURs, PBRERs and PADERs for assigned products including planning, preparation and finalization of reports.
• preparation of RMPs and signal management reports.
• Preparing and updating aggregate report calendars in accordance to competent regulatory authorities.
• Generating and reviewing of line listings and summary tabulations.
• Retrieving and reviewing of literature for inclusion in aggregate reports.
• Involve in internal and external audits and inspections.
• Plan, organize and Manage daily work to meet internal timelines.
• Interface with other functional groups, relevant stake holders as needed.
• Perform reconciliation with clients.
• Handling/supporting PV meetings, client calls, MOM drafting etc.
• Monitoring Health authority websites for latest updates.
• Initiate CAPA in case of any process non-conformance.
• Archiving of final documents in accordance to SOPs.
• Training other pharmacovigilance team associates on relevant company procedures, latest Regulations and Guidelines.
• Any other PV duties as assigned by the management from time to time.