Portfolio Safety Scientist

Proclinical are recruiting Portfolio Safety Scientist for a global business. This is a contract role and is located in Basel, with the availability to work remotely from home. Our client is focused on detecting innovative remedies.

**Responsibilities**:

- Offer expert involvement to the development of the product safety method.
- Expand and uphold a proficient understanding of the safety profile of the allocated product(s) as well as understanding of the applicable strategic context (e.g., disease under study, safety profile of competitors, mechanism of action).
- Accountable for signal detection and management activities involving, but not limited to STAR maintenance, ISMP maintenance.
- Add to the review of safety assessments and drug safety reports for signals or problems (including, product quality) or in response to Regulatory Authority requests.
- Take responsibility for risk management activities involving the preparation and maintenance of CCDS, labelling document maintenance (including IB), risk communications, RMP, REMS.
Oversee the formulation and preservation of safety sectors of the Company Core Data Sheet and/or Reference Safety Information in the IB.
- Analysis of clinical protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF) and any other related documents to warrant arrangement with the safety strategy and ensure the suitability of risk management strategies and risk communication.
- Contribute and/or lead the development of the safety components of the Target Product Profile (TPP), key claims and other lifecycle strategic planning documents (e.g., IDCP, CDP).
- Accountable for the safety components of study reports, aggregate reports and high-level regulatory documents.
- Display manners consistent with the company's values and engenders confidence from senior management.
- Enthusiastically emulate and role model the company's values, culture (mindset and behaviour), the company's core competencies and PD/PDS strategy and drive for similar performance across relevant team.
- Comprehend how safety activities influence the company development and commercialisation objectives and take procedures to maximise safety value to the organisation.
- Validate independence and high capability in the conduct of all safety science tasks.
- Authenticate and preserve co-operative working associations with all crucial stakeholders, and internal and external clients and guarantee the same across relevant teams.
- Constantly conform with all governing laws, regulations, QMS, company standard operating procedures (SOPs) and any other guidelines.
- Other duties may be designated to the place holder.
**Skills & Requirements**:

- Educated to a degree level within a Life Science discipline.
- At least 5 to 7 years of applicable hands on experience in Safety/Pharmacovigilance.
- Real-world experience with clinical trial and mature products safety.
- Practical operative experience with Risk Management Plan, Protocols, DSR, DSUR, CSR, IB, Adverse Events, etc.
Exhibited the capability to manage and impact, with and without authority, in a global matrix setting.
- Demonstrated success in producing and supporting solid relationships with internal and external business partners across an organisation to generate positive partnerships.
- Indication of proactive, structured thinking with the capacity to swiftly respond to a developing and intricate atmosphere.
- Implement complicated data analysis / statistical systems to assess, understand and display scientific data with clarity.
- Exceptional written and verbal communication skills.
- Robust presentation skills, operative at summarising and exhibiting the significant considerations and decision points.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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