RISK MANAGMENT PHYSICIAN

Settore

Sales & Marketing

Azienda

Our client, an important multinational pharmaceutical company with a global presence, is looking for a:

Descrizione

RISK MANAGEMENT PHYSICIAN

The incumbent will be responsible for assisting the Risk Management Head in managing aspects impacting on the safety profile of company products in the Department for Global Phamacovigilance. The candidate will take responsibility of monitoring actively and continue assessment of safety profile through systematic signal detection analysis and critical review of aggregate safety data and literature during all phases of the life cycle of the company medicinal products contributing in preparation of Safety Committee meetings and drafting meetings minutes Contributing in single case assessments (ICSRs and SAEs from clinical trials), with provision of medical and PV expertise Contributing in single case assessments (ICSRs and SAEs from clinical trials), with provision of medical and PV expertise providing support in the preparation and update of standard operating procedures related to the risk management activities providing support in responding to inquiries from internal sources including affiliates, and external sources as well as support for licensing activities, regulatory authorities inspection, company audits contributing in writing and updating company core data sheets related to the company marketed products assisting for the preparation and maintenance of Pharmacovigilance Risk Management Plans (PV RMPs) including coordination with other functions associated activities Assisting for the preparation and maintenance of Pharmacovigilance Risk Management Plans (PV RMPs) and implementation of risk minimization measures providing support in the preparation of aggregate reports (PSURs, DSURs) and ad hoc safety reports and performing a monitoring of selected health authority websites (e.g. EMA, PRAC).

The candidate has a Degree in Medicine. Prior experience in pharmacovigilance, clinical development or medical affairs are add value for the position. It's essential for the positions Good knowledge of standard Office package, team working, problem-solving, decision making abilities and English fluent.

Location: Emilia Romagna

Luogo di lavoro:

Parma

Disponibilità:

Assunzione diretta

Tipologia:

Full Time

Data pubblicazione:

17/05/2018

Codice annuncio:

500212618

Visualizzazioni annuncio:

1

Nome filiale:

Team Managers Exp.

Numero di candidati ricercati:

1
NOTE LEGALI:
Experis è una compagnia eticamente responsabile. Il servizio è gratuito. I candidati ambosessi (L.903/77 - D.Lgs. n.198/2006) sono invitati a leggere l'informativa Privacy su www.experis.it Aut. Min. Prot. N. 1116 - SG - del 26/11/04.
Il titolare della registrazione e/o candidatura dichiara di essere a conoscenza delle sanzioni penali previste in caso di dichiarazioni mendaci o contenenti dati non più rispondenti a verità come previsto dal D.P.R. nº445 del 28.12.2000

RISK MANAGMENT PHYSICIAN

Parma
Assunzione diretta
Full Time
17/05/2018
500212618
1
Team Managers Exp.
1

Settore

Sales & Marketing

Azienda

Our client, an important multinational pharmaceutical company with a global presence, is looking for a:

Descrizione

RISK MANAGEMENT PHYSICIAN

The incumbent will be responsible for assisting the Risk Management Head in managing aspects impacting on the safety profile of company products in the Department for Global Phamacovigilance. The candidate will take responsibility of monitoring actively and continue assessment of safety profile through systematic signal detection analysis and critical review of aggregate safety data and literature during all phases of the life cycle of the company medicinal products contributing in preparation of Safety Committee meetings and drafting meetings minutes Contributing in single case assessments (ICSRs and SAEs from clinical trials), with provision of medical and PV expertise Contributing in single case assessments (ICSRs and SAEs from clinical trials), with provision of medical and PV expertise providing support in the preparation and update of standard operating procedures related to the risk management activities providing support in responding to inquiries from internal sources including affiliates, and external sources as well as support for licensing activities, regulatory authorities inspection, company audits contributing in writing and updating company core data sheets related to the company marketed products assisting for the preparation and maintenance of Pharmacovigilance Risk Management Plans (PV RMPs) including coordination with other functions associated activities Assisting for the preparation and maintenance of Pharmacovigilance Risk Management Plans (PV RMPs) and implementation of risk minimization measures providing support in the preparation of aggregate reports (PSURs, DSURs) and ad hoc safety reports and performing a monitoring of selected health authority websites (e.g. EMA, PRAC).

The candidate has a Degree in Medicine. Prior experience in pharmacovigilance, clinical development or medical affairs are add value for the position. It's essential for the positions Good knowledge of standard Office package, team working, problem-solving, decision making abilities and English fluent.

Location: Emilia Romagna
NOTE LEGALI:
Experis è una compagnia eticamente responsabile. Il servizio è gratuito. I candidati ambosessi (L.903/77 - D.Lgs. n.198/2006) sono invitati a leggere l'informativa Privacy su www.experis.it Aut. Min. Prot. N. 1116 - SG - del 26/11/04.
Il titolare della registrazione e/o candidatura dichiara di essere a conoscenza delle sanzioni penali previste in caso di dichiarazioni mendaci o contenenti dati non più rispondenti a verità come previsto dal D.P.R. nº445 del 28.12.2000