Medical Safety Writer

7 giorni fa

Parma, Italia CROMSOURCE A tempo pieno

**Location: Italy
- Home and office based**
**Schedule: Full Time, Permanent**

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds.

TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Medical Safety Writer to join one of our clients, one of the most innovative pharmaceutical company in the world.

Scope of the role:
Assisting the Head of Risk Management Unit in the maintenance of products' registration worldwide and in supporting the clinical development, by means of planning, managing and drafting aggregate reports' and related activities.

**Job specific tasks and responsibilities**:
Planning of Periodic Safety Update Reports (PSURs)/Periodic Benefit-Risk Reports (PBRERs) related to corporate products and oversight of the PSUR planning for non-corporate (local) products
Track the EU PSURs submissions into the Regulatory Data management system
Prepare, maintain and submit PSURs)/PBRERs and other reports or documents related to requests from Health Authorities (e.g. Requests for Supplementary Information
- RSI)
Assist the Risk management physician in preparing safety communications (e.g. DHPC package)
Monitor that data used for aggregates are up-to-date (both at Corporate and Affiliates level) and cooperate with GPV Office for regulatory compliance analysis and report generation
Participate in audit and inspection activities

**Education and Experience**:
Bachelor or Master degree in medicine, PhD or similar in the field of Biosciences
Minimum 5 years of experience in medical safety writing

**Specific Role Requirements and Skills**:
Excellent communication, interpersonal and leadership skills
Strategic thinking, effective judgement, problem solving and decision-making skills
Planning, organizational and analytical skills, with a detail
- and result-oriented approach
Proven ability in managing performance and projects, thanks to a deep expertise in medical safety writing activities (e.g. preparation of aggregate reports)
Ability to organize and prioritize tasks both individually and across team to achieve established deadlines while maintaining high-quality performances
Deep and up-to-date knowledge of local/ international reporting and regulatory regulations to ensure compliance
Knowledge of safety database and other concerned data management systems

**The Benefits of Working for TalentSource in Italy**:
Meal vouchers
Mobile phone if requested by the Line Manager
Dedicated Line Manager
Monthly meetings with line manager
Full performance and development process with end of year reviews
Team events and end of year party
Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
Employee satisfaction survey - your feedback is important for continuous improvement

**Job Types**: Full-time, Permanent

Educación:

- Bachelor's (Obligatorio)

Experiência:

- Medical Safety Writing: 5 años (Obligatorio)

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