Medical Safety Writer Parma

Medical Safety Writer
Parma
Emilia Romagna, Parma

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)