Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Director, Global Drug Safety Leader

Company: Planet Pharma Staffing Limited
Location: Switzerland
Reference: SCPVDIR
Closing Date: 28 Feb 18
Type: Permanent
Salary (£): 100,000+
Benefits: Attractive

Job Summary:

A high level opportunity has arisen with an innovative biotech in Switzerland specialising in biosimilar products with a strong pipeline in both development and pre-development. This is an excellent opportunity for a senior candidate with PV expertise wanting to play a lead role in an exciting company!

Requirements:

Overview:

The role of the Global Biosimilars Safety Product Leader (BSPL) is to ensure effective proactive safety strategies for the assigned biosimilars product(s) be it a development compound or a marketed product; provision of recommendations and guidance concerning potential and/or established product risks and suitable risk management and mitigation strategies during clinical development and thereafter, as well as ongoing comparative safety and benefit-risk evaluation for the assigned biosimilar products. This includes the medical evaluation of single cases; signal detection and evaluation activities; compilation of periodic safety reports, drafting of risk management plans and other regulatory documents.

For the assigned product or products, either directly or through effective delegation to other members of the GDS Product Team:

  • ensure provision of a clearly defined safety strategy that serves to characterize the comparative safety profile of the biosimilar product(s) against the respective originator or reference product, and to ensure that action plans are in place which are consistent with this strategy;
  • ensure appropriate oversight of the emerging safety profile of the biosimilar product(s), including review of individual case safety reports, signal detection and evaluation, periodic reporting, risk-benefit evaluation and risk management.
  • ensure that significant emerging signals or safety issues are escalated appropriately within the company;
  • ensure adequate consideration of safety aspects in the design, conduct, analysis and reporting of clinical trials
  • maintain an comprehensive level of knowledge about the biosimilar product(s) and the corresponding originator or reference product and the therapeutic area;
  • coach, support and help develop other staff in the CSPV group, or other functions and teams in the Unit as required;
  • represent CSPV on cross-functional teams for the biosimilar product(s) ensuring that all negotiated and agreed deliverables and deadlines for these teams are met (may be delegated as appropriate);
  • represent CSPV on safety aspects for the product externally, e.g. engagement with DSMBs / IDMCs, preparation for and attendance at regulatory authority meetings, interactions with external advisers or opinion leaders, collaboration with colleagues from partnership companies for co-development or co-marketing etc;
  • provide product or TA-specific training and safety training to non-safety colleagues, as required;
  • ensure effective communication of product-related aspects in regulatory authority inspections.
  • Provide strategic safety leadership for one or more biosimilar product(s)
  • Act as a member of a biosimilar project, product or program team as appropriate
  • Provide a single initial point of contact for all aspects relating to the safety of the assigned biosimilar product(s)
  • Present to oversight committees on aspects of product specific safety

Work Experience:

  • Industry experience, preferably including both clinical development and pharmacovigilance experience (including medical safety evaluation and safety based decision making)
  • Excellent knowledge of product development process and experience of cross-functional team work.
  • Preferentially prior experience with NDA/BLA or equivalent regulatory submissions or working experience from a Regulatory Agency on reviewing submission files
  • First-hand experience in handling safety issues related to known target organ toxicities (e.g. hepatic, renal, haematological) and good understanding of either the oncology or rheumatology therapeutic area
  • Professional experience in an international environment
  • Several years of industry experience (minimum 5 years)

Competencies:

  • Strong, mature project leadership and influencing skills
  • Entrepreneurial thinking and striving to move project forward, within budget and timelines
  • Strong team player and excellent networking skills
  • Proven ability to chair meetings effectively
  • Solution and results orientated
  • Willing to cope with resistance and problems; demonstrated ability to work under pressure and achieving strict timeline targets

Education:

  • MD with broad clinical experience or Master of Science/Ph D with profound work experience in pharmacovigilance area
  • Excellent verbal and written communication skills (in English language)
     

Salary/Package

Attractive basic salary + benefits

About Planet Pharma 
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering. 

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com

To apply 
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Sam Chapple on +44 (0)20 3868 8607 or e-mail on schapple@planet-pharma.co.uk

If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!

Keywords 

Pharmacovigilance, pv, director, Switzerland, pharmaceutical, biosimilars, biotech

 

Apply for this job: Director, Global Drug Safety Leader

Contact Information:

Address:  Head Office
10 Greycoat Place, London,
SW1P 1SB
England
Tel:  +44 203 868 1000
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.