Responsabilities: 

I-Establishing    and maintaining   phannacovigilance     system.

2-Completing   Phannacovigilance     training   for the compnay.

3-Preparing   pharmacovigilance     reports  according  to companie's   PY  SOP.

4-taking in charge the requests  from Health  Authorities  as single contact point for the Health Authorities    in 24-hour   basis.

5-Providing    Health  Authorities    with  any  other  information    relevant   to product   safety.

6-0verview    of the safety  profiles  and any  emerging   safety  concerns  for the  company's drugs.

7-Declaring  to CNPM adverse reactions  cases reported  to the company  within the time-limits

stipulated  in Chapter VI, determined  by the CNPM,  and in CrOMS  format. Additionally,  to any new information  collected  as part of the follow-up  of these adverse reactions,  according to the same time-frames  and in the same format  (transferred  via the professional  mailbox provided  by the CNPM).

8-Contact   the  reporter   for additional    information    if any  is required.

9-Transferring  periodic  safety update  reports  (PSURSIPBRERS);

l O-Submitting risk management  plans to CNPM,

l l-Submitting   the pharmacovigilance   system master  file summary  (PSMF summary)  to

CNPM,

I2-Submitting   the European  pharmacovigilance   system  master file (PSMF) upon request,

13-Responding  to requests  for documentation   from the CNPM,

14-Working  with the CNPM to ensure that investigations   evaluating  the beriefit/risk  ratio of its marketed  products  are properly  implemented.

IS-Mention  the contact details of the CNPM  on the local Package Leaflets/Summary   of Product  Characteristics  (SmPC)  of health products.