Pharmacovigilance Supervisor

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.