Head of Medical Safety Science

at  TSP A Syneos Health Company

Description
Our client, a leading and fast-growing Pharma company is currently expanding and looking of their new Head of Medical Safety Science. You will have global responsibility for safety sciences support of all development and marketed products in their portfolio to meet GVP requirements, and will be leading a team in the Global Pharmacovigilance department which covers the drug safety surveillance, signal detection, safety evaluation, and safety management. You will join a very passionate and competent team where a wide collaboration and an international mindset are key factors in order to succeed.
The Head, MSS reports into the VP, Head of Pharmacovigilance and Global Drug Safety, who is located in Palo Alto, California.

QUALIFICATIONS

You hold a relevant professional health care degree (M.D. Preferred) with appropriate clinical experience and minimum 10 years of experience within the pharmaceutical or
biotechnology industries. You have extensive experience in a Medical Safety Sciences related role, with oversight of safety sciences fields and specific experience in epidemiology, quantitative methods, signal detection, data mining and benefit-risk. Furthermore, you have a proven track record of addressing and managing complex safety issues using scientific approaches in the pre-approval and post-approval environments. Expert knowledge of FDA safety regulations, ICH Guidelines, and safety databases is required.
Finally, you are proficient in English at a professional level, both written and spoken.
- This role can be based anywhere in Europe -
TSP Talent Solutions and our customers are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)

• Management of a team of Medical Safety Scientists, Medical Safety Directors and other safety experts.
• Provide strategic oversight of the Medical Review of Individual Case Safety Reports (ICSR).
• Leading teams for safety science activities related to MAA and NDA filing.
• Providing expert guidance in responding to health authority safety queries.
• Building strong professional working relationship with both internal and external stakeholders.

Criteria of success in the role will be to:

• Work effectively, independently, and collaboratively.
• Have couple of hours of overlap of work hours with colleagues based in Palo Alto, California.
• Demonstrate strong organizational skills, detail oriented and adapts in a dynamic, fast paced environment.
• Demonstrate ownership, initiative, and prioritization.
• Have ability to interact as an effective team player encouraging collaboration in a multifunctional and multidisciplinary team setting.
• Excellent communication skills, both written and verbal.
• Demonstrate strategic evaluation, analysis, and decision-making skills.