Janssen Research & Development area develops treatments that improve the health and lifestyles of people worldwide. R&D development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine. The Principal Scientist Technical Integrator is the DPD (Drug Product Development) representative and single point of contact on the CMC new product development teams.
Post: Senior Safety Specialist – Local Drug Safety
Candidate Profile
Medical Officer or Pharmacist
4-5 years relevant experience in Pharmacovigilance, Regulatory Affairs.
Knowledge about PV Global and local regulations
SDEA, Audit and Inspection management
Knowledge about end to end Pharmacovigilance processes
Job Description
a. This position is an important one and will play a key role in ensuring Pharmacovigilance system in South Asia to fulfil the responsibility for the coordination and execution of all Pharmacovigilance (PV) activities in the pharmaceutical sector and bringing value to the patients using our products.
b. Oversight of the PV System & Overall responsibilities
c. Act as Local Nominated Person (including back-up nominated person)
d. Collaborate with Case Management team in planning and ensuring timely submission of Aggregate Reports according to local regulations.
e. Establish adequate collaboration with the Case Management team to provide local data as required to support the preparation of Aggregate Safety Summary reports (PBRER/PSUR, DSUR, etc.), undertake local review and submission of PBRERs/PSURs, provide due dates to GMS and promote synchronization with the Global PSUR schedule, in accordance with local regulatory requirements.
f. Oversight of data generating activities to ensure appropriate review and reporting process are included in project documents for reporting potential AEs (e.g., patient support programs, market research surveys, internet sites), as applicable.
g. Establish Product knowledge with focus on safety profiles, Therapeutic Area and Disease Pathway knowledge supporting the needs of the local Medical Affairs and Marketing organization in collaboration with the International Medical Safety leader.
h. Act as safety expert in cross-functional team meetings and perform training on safety relevant aspects, as appropriate.
i. Provide Risk Management Plan (RMP) status updates.
j. Prepare local RMPs/Addendums, etc. as applicable.
k. Ensure implementation of Global Pharma and Consumer Cross-Pharma PV relevant Procedural Documents as applicable and/or write, validate and implement the Local Implementation Documents (LID) for Regional / IPV Standard Operating Procedures (SOPs)/Working Practices and verify adherence. Where appropriate develop local controlled procedures to cover local aspects of PV activities.
m. Management of local PVAs and ensure local implementation, including LSU training and adherence to PVAs.
n. Function as IPV Lead reviewer, to have PVA implementation and oversight
o. Focused engagement in local industry associations and drive local policy shaping initiatives based on One J&J Voice. Act as the local PV contact person for all PV audits and inspection and coordinate the audit and inspection preparations for internal PV audits (e.g., Bioresearch, p. Quality & Compliance (BRQC)) and external PV inspections.
r. Assist inspectors/auditors, support document requests in collaboration with relevant stakeholders.
s. Address follow-up actions from findings.
t. Ensure that a process is in place for reporting of AEs after hours, and testing is documented as per Global and Regional requirements.
Additional Information
Experience : 4-5 years
Qualification : Medical Officer or Pharmacist
Location : Greater Mumbai, Maharashtra
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : R&D
End Date : 30th July, 2023
