job title: Senior Associate PV-aggregate (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:

• 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.

Apply for this Position

Submit Application