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 setting 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.

📌 Senior Associate PV (Aggregate) (India)
🏢 Advity Research
📍 India